Journal publications by FDA oncology medical reviewers

The Oncology Center of Excellence supports a robust publications program that assists FDA oncology/hematology staff in other centers to conceptualize and write manuscripts for publication in leading peer-reviewed scientific journals.

Oncology reviewers from the Office of Oncologic Diseases, working with clinical pharmacology, toxicology, and statistical reviewers, write summaries of many cancer drug approvals. FDA oncology staff also are encouraged to develop research articles and perspectives on important topics in cancer drug development, often in collaboration with academic and regulatory experts outside of FDA and internationally. The OCE Communications Program supports authors with editing and administrative publication services.

Following are publications by or with the participation of FDA oncology/hematology staff.

2022

1. Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy: A Pooled Analysis of Trials in the US Food and Drug Administration Database. Anscher MS, Arora S, Weinstock C, Amatya A, Bandaru P, Tang C, Girvin AT, Fiero MH, Tang S, Lubitz R, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA. JAMA Oncol. 2022 Feb 1;8(2):232-240. doi: 10.1001/jamaoncol.2021.6439. Erratum in: JAMA Oncol. 2022 Feb 1;8(2):306. PMID: 34989781; PMCID: PMC8739815.

2. Call to Action for Improving Oral Anticancer Agent Adherence. Levit LA, Arora S, Kluetz PG, Magnuson A, Rahman A, Harvey RD. J Clin Oncol. 2022 Apr 1;40(10):1036-1040. doi: 10.1200/JCO.21.02529. Epub 2022 Jan 6. PMID: 34990218.

3. In search of autophagy biomarkers in breast cancer: Receptor status and drug agnostic transcriptional changes during autophagy flux in cell lines. Mascia F, Mazo I, Alterovitz WL, Karagiannis K, Wu WW, Shen RF, Beaver JA, Rao VA. PLoS One. 2022 Jan 6;17(1):e0262134. doi: 10.1371/journal.pone.0262134. PMID: 34990474; PMCID: PMC8735604.

4. Achieving robust somatic mutation detection with deep learning models derived from reference data sets of a cancer sample. Sahraeian SME, Fang LT, Karagiannis K, Moos M, Smith S, Santana-Quintero L, Xiao C, Colgan M, Hong H, Mohiyuddin M, Xiao W. Genome Biol. 2022 Jan 7;23(1):12. doi: 10.1186/s13059-021-02592-9. PMID: 34996510; PMCID: PMC8740374.

5. External control arms in oncology: current use and future directions. Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10. PMID: 35026413.

6. Accelerated Approval Is Not Conditional Approval: Insights From International Expedited Approval Programs. Mehta GU, de Claro RA, Pazdur R. JAMA Oncol. 2022 Mar 1;8(3):335-336. doi: 10.1001/jamaoncol.2021.6854. PMID: 35050302.

7. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer. Royce M, Osgood C, Mulkey F, Bloomquist E, Pierce WF, Roy A, Kalavar S, Ghosh S, Philip R, Rizvi F, Mixter BD, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. J Clin Oncol. 2022 Apr 10;40(11):1155-1162. doi: 10.1200/JCO.21.02742. Epub 2022 Jan 27. PMID: 35084948; PMCID: PMC8987222.

8. Importing oncology trials from China: a bridge over troubled waters? Singh H, Pazdur R. Lancet Oncol. 2022 Mar;23(3):323-325. doi: 10.1016/S1470-2045(22)00071-7. Epub 2022 Feb 4. PMID: 35131039.

9. Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials. Kanapuru B, Fernandes LL, Fashoyin-Aje LA, Baines AC, Bhatnagar V, Ershler R, Gwise T, Kluetz P, Pazdur R, Pulte E, Shen YL, Gormley N. Blood Adv. 2022 Mar 22;6(6):1684-1691. doi: 10.1182/bloodadvances.2021005482. PMID: 35114691; PMCID: PMC8941450.

10. FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as single agents for first-line treatment of advanced/metastatic PD-L1 high NSCLC. Akinboro O, Larkins E, Pai-Scherf LH, Mathieu LN, Ren Y, Cheng J, Fiero MH, Fu W, Bi Y, Kalavar S, Jafri S, Mishra-Kalyani PS, Fourie Zirkelbach J, Li H, Zhao H, He K, Helms WS, Chuk MK, Wang M, Bulatao I, Herz J, Osborn BL, Xu Y, Liu J, Gong Y, Sickafuse S, Cohen R, Donoghue M, Pazdur R, Beaver JA, Singh H. Clin Cancer Res. 2022 Jan 31:clincanres.3844.2021. doi: 10.1158/1078-0432.CCR-21-3844. Epub ahead of print. PMID: 35101885.

11. Better by design: a regulatory perspective on rationalizing combination selection and development. Immuno-Oncology Insights. Interview with Elaine Chang.

12. FDA Approval Summary: Ivosidenib for the treatment of patients with advanced unresectable or metastatic, chemotherapy refractory cholangiocarcinoma with an IDH1 mutation. Casak SJ, Pradhan S, Fashoyin-Aje LA, Ren Y, Shen YL, Xu Y, Chow ECY, Xiong Y, Zirklelbach JF, Liu J, Charlab R, Pierce WF, Fesenko N, Beaver JA, Pazdur R, Kluetz PG, Lemery SJ. Clin Cancer Res. 2022 Mar 8:clincanres.4462.2021. doi: 10.1158/1078-0432.CCR-21-4462. Epub ahead of print. PMID: 35259259.

13. Project Confirm: An Initiative to Promote Transparency of the Accelerated Approval Program for Oncology Indications. The ASCO Post. Mehta GU, Rizvi F, Kim T

14. Optimizing Clinical Trial Design for Patients with Non-muscle-invasive Bladder Cancer. Weinstock C, Agrawal S, Chang E. Eur Urol. 2022 Mar 15:S0302-2838(22)01655-4. doi: 10.1016/j.eururo.2022.02.014. Epub ahead of print. PMID: 35304001.

15. Clinical Evidence Generation During a Pandemic: Lessons Learned for Sustaining Progress. Rivera DR, Kluetz PG, Abdallah K, Agrawal S, Angus DC, Califf RM, Garrett-Mayer E, Hyer R, Lowy DR, Khleif SN. Cancer J. 2022 Mar-Apr 01;28(2):151-156. doi: 10.1097/PPO.0000000000000589. PMID: 35333502.

16. How to Get the Dose Right. The ASCO Post. Mirat Shah, Antiqur Rahman, Marc R. Theoret, and Richard Pazdur.

17. Exploring racial disparities in treatment patterns and outcomes for patients with multiple myeloma using real world data. Maignan K, Fashoyin-Aje LA, Torres AZ, Fernandes LL, Gwise T, Baxi SB, Roose JP, Rivera DR, Shen YL, Kluetz PG, Gormley NJ. Blood Cancer J. 2022 Apr 19;12(4):65. doi: 10.1038/s41408-022-00665-x. PMID: 35440047; PMCID: PMC9018767.

18. Reimagining patient-centric cancer clinical trials: a multi-stakeholder international coalition. Li BT, Daly B, Gospodarowicz M, Bertagnolli MM, Brawley OW, Chabner BA, Fashoyin-Aje L, de Claro RA, Franklin E, Mills J, Legos J, Kaucic K, Li M, The L, Hou T, Wu TH, Albrecht B, Shao Y, Finnegan J, Qian J, Shahidi J, Gasal E, Tendler C, Kim G, Yan J, Morrow PK, Fuchs CS, Zhang L, LaCaze R, Oelrich S, Murphy MJ, Pazdur R, Rudd K, Wu YL. Nat Med. 2022 Apr;28(4):620-626. doi: 10.1038/s41591-022-01775-6. PMID: 35440725.

19. FDA approval summary: decitabine and cedazuridine tablets for myelodysplastic syndromes. Kim N, Norsworthy KJ, Subramaniam S, Chen H, Manning ML, Kitabi E, Earp J, Ehrlich LA, Okusanya OO, Vallejo J, Gehrke BJ, de Claro RA, Pazdur R. Clin Cancer Res. 2022 Apr 18:clincanres.4498.2021. doi: 10.1158/1078-0432.CCR-21-4498. Epub ahead of print. PMID: 35435961.

20. FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma. Bouchkouj N, Zimmerman M, Kasamon YL, Wang C, Dai T, Xu Z, Wang X, Theoret M, Purohit-Sheth T, George B. Oncologist. 2022 Apr 11:oyac054. doi: 10.1093/oncolo/oyac054. Epub ahead of print. PMID: 35403693.

21. Development of Tissue-Agnostic Treatments for Patients with Cancer. Annual Review of Cancer Biology. Lemery S, Fashoyin-Aje L, Marcus L, Casak S, Schneider J, Theoret M, Kluetz P, Pazdur R, Beaver J.

22. FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma. Merino M, Kasamon Y, Li H, Ma L, Leong R, Zhou J, Reaman G, Chambers W, Richardson N, Theoret M, Pazdur R, Gormley N. Pediatr Blood Cancer. 2022 May 13:e29602. doi: 10.1002/pbc.29602. Epub ahead of print. PMID: 35561013.

23. Analysis of Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy Using Pooled Trial Data Matched by Propensity Score-Reply. Weinstock C, Amatya A, Beaver JA. JAMA Oncol. 2022 May 5. doi: 10.1001/jamaoncol.2022.0880. Epub ahead of print. PMID: 35511133.

24. The saga of PI3K inhibitors in haematological malignancies: survival is the ultimate safety endpoint. Richardson NC, Kasamon Y, Pazdur R, Gormley N. Lancet Oncol. 2022 May;23(5):563-566. doi: 10.1016/S1470-2045(22)00200-5. Epub 2022 Apr 14. PMID: 35429996.

25. Time to deterioration of symptoms or function using patient-reported outcomes in cancer trials. Fiero MH, Roydhouse JK, Bhatnagar V, Chen TY, King-Kallimanis BL, Tang S, Kluetz PG. Lancet Oncol. 2022 May;23(5):e229-e234. doi: 10.1016/S1470-2045(22)00021-3. PMID: 35489354.

26. US Food and Drug Administration Analysis of Patient-Reported Diarrhea and Its Impact on Function and Quality of Life in Patients Receiving Treatment for Breast Cancer. Chen TY, King-Kallimanis BL, Merzoug L, Horodniceanu EG, Fiero MH, Gao JJ, Beaver JA, Bhatnagar V, Kluetz P. Value Health. 2022 Apr;25(4):566-570. doi: 10.1016/j.jval.2021.09.007. Epub 2021 Nov 9. PMID: 35365300.

27. Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events. King-Kallimanis BL, Bhatnagar V, Horodniceanu EG, Chen TY, Kluetz PG. Clin Trials. 2022 May 15:17407745221093935. doi: 10.1177/17407745221093935. Epub ahead of print. PMID: 35575012.

2021

1. Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples. Amatya AK, Fiero MH, Bloomquist EW, Sinha AK, Lemery SJ, Singh H, Ibrahim A, Donoghue M, Fashoyin-Aje LA, de Claro RA, Gormley NJ, Amiri-Kordestani L, Sridhara R, Theoret MR, Kluetz PG, Pazdur R, Beaver JA, Tang S. Clin Cancer Res. 2021 Nov 1;27(21):5753-5756. doi: 10.1158/1078-0432.CCR-20-4912. Epub 2021 Jun 11. PMID: 34117032; PMCID: PMC8563387.
2. Oncology approvals in 2020: a year of firsts in the midst of a pandemic. Amiri-Kordestani L, Pazdur R. Nat Rev Clin Oncol. 2021 Mar;18(3):129-130. doi: 10.1038/s41571-021-00477-1. PMID: 33514911; PMCID: PMC7844812.
3. Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration. Anderson KC, Auclair D, Adam SJ, Agarwal A, Anderson M, Avet-Loiseau H, Bustoros M, Chapman J, Connors DE, Dash A, Di Bacco A, Du L, Facon T, Flores-Montero J, Gay F, Ghobrial IM, Gormley NJ, Gupta I, Higley H, Hillengass J, Kanapuru B, Kazandjian D, Kelloff GJ, Kirsch IR, Kremer BE, Landgren O, Lightbody ED, Lomas OC, Lonial S, Mateos MV, Montes de Oca R, Mukundan L, Munshi NC, O'Donnell EK, Orfao A, Paiva B, Patel R, Pugh TJ, Ramasamy K, Ray J, Roshal M, Ross JA, Sigman CC, Thoren KL, Trudel S, Ulaner GA, Valente N, Weiss BM, Zamagni E, Kumar SK. Clin Cancer Res. 2021 Jul 28:clincanres.1059.2021. doi: 10.1158/1078-0432.CCR-21-1059. Epub ahead of print. PMID: 34321279.
4. FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA-Mutated Metastatic Castrate-Resistant Prostate Cancer. Anscher MS, Chang E, Gao X, Gong Y, Weinstock C, Bloomquist E, Adeniyi O, Charlab R, Zimmerman S, Serlemitsos-Day M, Ning YM, Mayrosh R, Fuller B, Trentacosti AM, Gallagher P, Bijwaard K, Philip R, Ghosh S, Fahnbulleh F, Diggs F, Arora S, Goldberg KB, Tang S, Amiri-Kordestani L, Pazdur R, Ibrahim A, Beaver JA. Oncologist. 2021 Feb;26(2):139-146. doi: 10.1002/onco.13585. Epub 2020 Nov 17. PMID: 33145877; PMCID: PMC7873319.
5. FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer. Arora S, Balasubramaniam S, Zhang H, Berman T, Narayan P, Suzman D, Bloomquist E, Tang S, Gong Y, Sridhara R, Turcu FR, Chatterjee D, Saritas-Yildirim B, Ghosh S, Philip R, Pathak A, Gao JJ, Amiri-Kordestani L, Pazdur R, Beaver JA. Oncologist. 2021 Jan;26(1):e164-e172. doi: 10.1002/onco.13551. Epub 2020 Oct 20. PMID: 33017510; PMCID: PMC7794199.
6. U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review. Arora S, Narayan P, Ison G, Berman T, Suzman DL, Wedam S, Prowell TM, Ghosh S, Philip R, Osgood CL, Gao JJ, Shah M, Krol D, Wahby S, Royce M, Brus C, Bloomquist EW, Fiero MH, Tang S, Pazdur R, Ibrahim A, Amiri-Kordestani L, Beaver JA. Clin Cancer Res. 2021 Oct 28. doi: 10.1158/1078-0432.CCR-21-2599. Epub ahead of print. PMID: 34711631.
7. U.S. FDA Drug Approvals for Breast Cancer - A Decade in Review. Arora S, Narayan P, Osgood CL, Wedam S, Prowell TM, Gao JJ, Shah M, Krol D, Wahby S, Royce M, Ghosh S, Philip R, Ison G, Berman T, Brus C, Bloomquist EW, Fiero MH, Tang S, Pazdur R, Ibrahim A, Amiri-Kordestani L, Beaver JA. Clin Cancer Res. 2021 Oct 28:clincanres.2600.2021. doi: 10.1158/1078-0432.CCR-21-2600. Epub ahead of print. PMID: 34711632.
8. "Dangling" Accelerated Approvals in Oncology. Beaver JA, Pazdur R. N Engl J Med. 2021 May 6;384(18):e68. doi: 10.1056/NEJMp2104846. Epub 2021 Apr 21. PMID: 33882220.
9. The Wild West of Checkpoint Inhibitor Development. Beaver JA, Pazdur R. N Engl J Med. 2021 Dec 15. doi: 10.1056/NEJMp2116863. Epub ahead of print. PMID: 34910860.
10. FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions. Bradford D, Larkins E, Mushti SL, Rodriguez L, Skinner AM, Helms WS, Price LSL, Zirkelbach JF, Li Y, Liu J, Charlab R, Turcu FR, Liang D, Ghosh S, Roscoe D, Philip R, Zack-Taylor A, Tang S, Kluetz PG, Beaver JA, Pazdur R, Theoret MR, Singh H. Clin Cancer Res. 2021 Apr 15;27(8):2130-2135. doi: 10.1158/1078-0432.CCR-20-3558. Epub 2020 Nov 25. PMID: 33239432.
11. FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma. Casak SJ, Donoghue M, Fashoyin-Aje L, Jiang X, Rodriguez L, Shen YL, Xu Y, Jiang X, Liu J, Zhao H, Pierce WF, Mehta S, Goldberg KB, Theoret MR, Kluetz PG, Pazdur R, Lemery SJ. Clin Cancer Res. 2021 Apr 1;27(7):1836-1841. doi: 10.1158/1078-0432.CCR-20-3407. Epub 2020 Nov 2. PMID: 33139264.
12. FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma. Casak SJ, Marcus L, Fashoyin-Aje L, Mushti SL, Cheng J, Shen YL, Pierce WF, Her L, Goldberg KB, Theoret MR, Kluetz PG, Pazdur R, Lemery SJ. Clin Cancer Res. 2021 Sep 1;27(17):4680-4684. doi: 10.1158/1078-0432.CCR-21-0557. Epub 2021 Apr 12. PMID: 33846198; PMCID: PMC8416693.
13. FDA Approval Summary: Selumetinib for Plexiform Neurofibroma. Casey D, Demko S, Sinha A, Mishra-Kalyani PS, Shen YL, Khasar S, Goheer MA, Helms WS, Pan L, Xu Y, Fan J, Leong R, Liu J, Yang Y, Windsor K, Ou M, Stephens O, Oh B, Reaman GH, Nair A, Shord SS, Bhatnagar V, Daniels SR, Sickafuse S, Goldberg KB, Theoret MR, Pazdur R, Singh H. Clin Cancer Res. 2021 Aug 1;27(15):4142-4146. doi: 10.1158/1078-0432.CCR-20-5032. Epub 2021 Mar 12. PMID: 33712511.
14. Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop. Chang E, Apolo AB, Bangs R, Chisolm S, Duddalwar V, Efstathiou JA, Goldberg KB, Hansel DE, Kamat AM, Kluetz PG, Lerner SP, Plimack E, Prowell T, Singh H, Suzman D, Yu EY, Zhang H, Beaver JA, Pazdur R, Weinstock C, Galsky MD. Nat Rev Urol. 2021 Sep 10. doi: 10.1038/s41585-021-00505-w. Epub ahead of print. PMID: 34508246.
15. Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health. Chang E, Pelosof L, Lemery S, Gong Y, Goldberg KB, Farrell AT, Keegan P, Veeraraghavan J, Wei G, Blumenthal GM, Amiri-Kordestani L, Singh H, Fashoyin-Aje L, Gormley N, Kluetz PG, Pazdur R, Beaver JA, Theoret MR. Oncologist. 2021 Oct;26(10):e1786-e1799. doi: 10.1002/onco.13887. Epub 2021 Jul 27. PMID: 34196068; PMCID: PMC8488782.
16. FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma. Chang E, Weinstock C, Zhang L, Charlab R, Dorff SE, Gong Y, Hsu V, Li F, Ricks TK, Song P, Tang S, Waldron PE, Yu J, Zahalka E, Goldberg KB, Pazdur R, Theoret MR, Ibrahim A, Beaver JA. Clin Cancer Res. 2021 Feb 15;27(4):922-927. doi: 10.1158/1078-0432.CCR-20-2275. Epub 2020 Sep 22. PMID: 32962979.
17. FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma. Chang E, Weinstock C, Zhang L, Fiero MH, Zhao M, Zahalka E, Ricks TK, Fourie Zirkelbach J, Qiu J, Yu J, Chen XH, Bhatnagar V, Goldberg KB, Tang S, Kluetz PG, Pazdur R, Ibrahim A, Beaver JA, Amiri-Kordestani L. Clin Cancer Res. 2021 Aug 20. doi: 10.1158/1078-0432.CCR-21-2334. Epub ahead of print. PMID: 34417198.
18. Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature. Cheng C, Nguyen MN, Nayernama A, Jones SC, Brave M, Agrawal S, Amiri-Kordestani L, Woronow D. Vasc Med. 2021 Oct;26(5):526-534. doi: 10.1177/1358863X211006470. Epub 2021 Apr 12. PMID: 33840328.
19. U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program. de Claro RA, Gao JJ, Kim T, Kluetz PG, Theoret MR, Beaver JA, Pazdur R. Clin Cancer Res. 2021 Jan 1;27(1):11-14. doi: 10.1158/1078-0432.CCR-20-2220. Epub 2020 Aug 19. PMID: 32816899.
20. Intercontinental collaboration in clinical trials for children and adolescents with cancer—A systematic review by ACCELERATE. De Rojas T, Pearson AJ, Scobie N, Knox L, Wariabharaj D, Kearns P, Vassal G, Reaman G. Cancer Med. 2021; 10: 8462– 8474. doi:10.1002/cam4.4356
21. Radiographic read paradigms and the roles of the central imaging laboratory in neuro-oncology clinical trials. Ellingson BM, Brown MS, Boxerman JL, Gerstner ER, Kaufmann TJ, Cole PE, Bacha JA, Leung D, Barone A, Colman H, van den Bent MJ, Wen PY, Alfred Yung WK, Cloughesy TF, Goldin JG. Neuro Oncol. 2021 Feb 25;23(2):189-198. doi: 10.1093/neuonc/noaa253. PMID: 33130879; PMCID: PMC7906061.
22. Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials. Fallah J, Zhang L, Amatya A, Gong Y, King-Kallimanis B, Bhatnagar V, Weinstock C, Suzman DL, Agrawal S, Chang E, Anscher MS, Chi DC, Xu JX, Brewer JR, Brave MH, Hadadi M, Theoret MR, Kluetz PG, Goldberg KB, Ibrahim A, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L, Singh H. Lancet Oncol. 2021 Sep;22(9):1230-1239. doi: 10.1016/S1470-2045(21)00334-X. Epub 2021 Jul 23. PMID: 34310904.
23. Promoting Inclusion of Members of Racial and Ethnic Minority Groups in Cancer Drug Development. Fashoyin-Aje L, Beaver JA, Pazdur R. JAMA Oncol. 2021 Oct 1;7(10):1445-1446. doi: 10.1001/jamaoncol.2021.2137. PMID: 34264279.
24. Review of patient-reported outcomes in multiple myeloma registrational trials: highlighting areas for improvement. Fernandes LL, Zhou J, Kanapuru B, Horodniceanu E, Gwise T, Kluetz PG, Bhatnagar V. Blood Cancer J. 2021 Aug 31;11(8):148. doi: 10.1038/s41408-021-00543-y. PMID: 34465728; PMCID: PMC8408214.
25. Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective. Flaherty KT, Doroshow JH, Galbraith S, Ribas A, Kluetz PG, Pazdur R, Theoret MR. Cancer Discov. 2021 Aug;11(8):1881-1885. doi: 10.1158/2159-8290.CD-21-0850. Epub 2021 Jul 21. PMID: 34290074; PMCID: PMC8340848.
26. Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis. Gao JJ, Cheng J, Prowell TM, Bloomquist E, Tang S, Wedam SB, Royce M, Krol D, Osgood C, Ison G, Sridhara R, Pazdur R, Beaver JA, Amiri-Kordestani L. Lancet Oncol. 2021 Nov;22(11):1573-1581. doi: 10.1016/S1470-2045(21)00472-1. Epub 2021 Oct 14. Erratum in: Lancet Oncol. 2021 Nov;22(11):e472. PMID: 34656225.
27. Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria. Gao JJ, Krol D, Narayan P, Cardoso F, Regan MM, Goetz MP, Hurvitz SA, Mauro L, Hodgdon C, Miller CP, Booth B, Bloomquist E, Ison G, Osgood C, Bhatnagar V, Fashoyin-Aje L, Pazdur R, Amiri-Kordestani L, Beaver JA. Ann Oncol. 2021 Aug;32(8):950-953. doi: 10.1016/j.annonc.2021.05.356. Epub 2021 May 13. PMID: 33991601.
28. FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer. Gao JJ, Osgood CL, Gong Y, Zhang H, Bloomquist EW, Jiang X, Qiu J, Yu J, Song P, Rahman NA, Chiu HJ, Ricks TK, Rizvi F, Hou S, Wilson W, Abukhdeir AM, Seidman J, Ghosh S, Philip R, Pierce WF, Bhatnagar V, Kluetz PG, Pazdur R, Beaver JA, Amiri-Kordestani L. Clin Cancer Res. 2021 Apr 15;27(8):2126-2129. doi: 10.1158/1078-0432.CCR-20-3474. Epub 2020 Nov 13. PMID: 33188141.
29. FDA Oncology Center of Excellence During COVID-19-Working for Patients With Cancer. Gao JJ, Pazdur R. JAMA Oncol. 2020 Dec 23. doi: 10.1001/jamaoncol.2020.6783. Epub ahead of print. PMID: 33355627.
30. Recommendations on eliminating racial disparities in multiple myeloma therapies: a step toward achieving equity in healthcare.Gormley N, Fashoyin-Aje L, Locke T, Unger J, Little RF, Nooka A, Mezzi K, Popa-McKiver M, Kobos R, Biru Y, Williams TH, Anderson KC. Blood Cancer Discov. 2021 Mar;2(2):119-124. doi: 10.1158/2643-3230.bcd-20-0123. PMID: 34179821; PMCID: PMC8224821.
31. Rapid real-world data analysis of patients with cancer, with and without COVID-19, across distinct health systems. Hwang C, Izano MA, Thompson MA, Gadgeel SM, Weese JL, Mikkelsen T, Schrag A, Teka M, Walters S, Wolf FM, Hirsch J, Rivera DR, Kluetz PG, Singh H, Brown TD. Cancer Rep (Hoboken). 2021 Oct;4(5):e1388. doi: 10.1002/cnr2.1388. Epub 2021 May 20. PMID: 34014037; PMCID: PMC8209944.
32. US Food and Drug Administration Support for Oncology Drug Development During COVID-19. Kadakia KT, Pazdur R, Shah A. JAMA Oncol. 2021 Jan 1;7(1):27-28. doi: 10.1001/jamaoncol.2020.4975. PMID: 33030504.
33. FDA Approval Summary: Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Kasamon YL, Price LSL, Okusanya OO, Richardson NC, Li RJ, Ma L, Wu YT, Theoret M, Pazdur R, Gormley NJ. Oncologist. 2021 Oct;26(10):879-886. doi: 10.1002/onco.13859. Epub 2021 Jul 1. PMID: 34132444; PMCID: PMC8488790.
34. Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO-Friends of Cancer Research Joint Research Statement. Kim ES, Uldrick TS, Schenkel C, Bruinooge SS, Harvey RD, Magnuson A, Spira A, Wade JL, Stewart MD, Vega DM, Beaver JA, Denicoff AM, Ison G, Ivy SP, George S, Perez RP, Spears PA, Tap WD, Schilsky RL. Clin Cancer Res. 2021 May 1;27(9):2394-2399. doi: 10.1158/1078-0432.CCR-20-3852. Epub 2021 Feb 9. PMID: 33563632.
35. FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions. Kim J, Bradford D, Larkins E, Pai-Scherf LH, Chatterjee S, Mishra-Kalyani PS, Wearne E, Helms WS, Ayyoub A, Bi Y, Sun J, Charlab R, Liu J, Zhao H, Liang D, Ghosh S, Philip R, Pazdur R, Theoret MR, Beaver JA, Singh H. Clin Cancer Res. 2021 Oct 15;27(20):5452-5456. doi: 10.1158/1078-0432.CCR-21-0967. Epub 2021 May 27. PMID: 34045295.
36. Patient-Reported Outcomes After Treatment Discontinuation: Commercial Clinical Trial Data From Four Cancer Types. Value Health. King-Kallimanis BL, Lederer NM, Kim J, Nair A, Horodniceanu E, Bhatnagar V, Kluetz PG. 2021 Sep;24(9):1302-1307. doi: 10.1016/j.jval.2021.04.1279. Epub 2021 Jun 24. PMID: 34452710.
37. The FDA's patient-focused drug development initiative. Kluetz PG, Bhatnagar V. Clin Adv Hematol Oncol. 2021 Feb;19(2):70-72. PMID: 33596186.
38. FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs. Kluetz PG, Keegan P, Demetri GD, Thornton K, Sul J, Kim J, Katzen H, Burke LB, Harvey RD, Alebachew E, Agrawal S, Nair A, Donoghue M, Pierce WF, Shord SS, Gao JJ, Pazdur R. Clin Cancer Res. 2021 Feb 15;27(4):916-921. doi: 10.1158/1078-0432.CCR-20-3213. Epub 2020 Nov 30. PMID: 33257426.
39. Advancing Assessment, Analysis, and Reporting of Safety and Tolerability in Cancer Trials. Kluetz PG, King-Kallimanis BL, Suzman D, Chang E, Brave MM, Weinstock C, Bhatnagar V, Beaver JA, Chuk MK. J Natl Cancer Inst. 2021 May 4;113(5):507-508. doi: 10.1093/jnci/djaa135. PMID: 32857840; PMCID: PMC8096361.
40. FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review. Koch AL, Vellanki PJ, Drezner N, Li X, Mishra-Kalyani PS, Shen YL, Xia H, Li Y, Liu J, Zirkelbach JF, Palazov E, Gamarian A, Choo Q, Girčys A, Rohr UP, Fesenko N, Spillman D, Pazdur R, Beaver JA, Singh H. Clin Cancer Res. 2021 Jul 22. doi: 10.1158/1078-0432.CCR-21-1034. Epub ahead of print. PMID: 34301748.v
41. Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience. Lee EQ, Selig W, Meehan C, Bacha J, Barone A, Bloomquist E, Chang SM, de Groot JF, Galanis E, Hassan I, Kalidas C, Khasraw M, Kvedar JC, Lassman AB, Puduvalli V, Sahebjam S, Schwamm LH, Tamir S, Welch M, Yung WKA, Zadeh G, Arons D, Wen PY. Neuro Oncol. 2021 Aug 2;23(8):1252-1260. doi: 10.1093/neuonc/noab082. PMID: 33822177; PMCID: PMC8083574.
42. Roadmap to 2030 for Drug Evaluation in Older Adults. Liu Q, Schwartz JB, Slattum PW, Lau SWJ, Guinn D, Madabushi R, Burckart G, Califf R, Cerreta F, Cho C, Cook J, Gamerman J, Goldsmith P, van der Graaf PH, Gurwitz JH, Haertter S, Hilmer S, Huang SM, Inouye SK, Kanapuru B, Pirmohamed M, Posner P, Radziszewska B, Keipp Talbot H, Temple R. Clin Pharmacol Ther. 2021 Oct 16. doi: 10.1002/cpt.2452. Epub ahead of print. PMID: 34656074.
43. Clinical and immunologic impact of short-course enzalutamide alone and with immunotherapy in non-metastatic castration sensitive prostate cancer. Madan RA, Karzai F, Donahue RN, Al-Harthy M, Bilusic M, Rosner II, Singh H, Arlen PM, Theoret MR, Marté JL, Cordes L, Couvillon A, Hankin A, Williams M, Owens H, Lochrin SE, Chau CH, Steinberg S, Figg WD, Dahut W, Schlom J, Gulley JL. J Immunother Cancer. 2021 Mar;9(3):e001556. doi: 10.1136/jitc-2020-001556. PMID: 33664086; PMCID: PMC7934713.
44. Cabozantinib plus docetaxel and prednisone in metastatic castration-resistant prostate cancer. Madan RA, Karzai FH, Al Harthy M, Petrylak DP, Kim JW, Arlen PM, Rosner I, Theoret MR, Cordes L, Bilusic M, Peer CJ, Dawson NA, Couvillon A, Hankin A, Williams M, Chun G, Owens H, Marte JL, Lee MJ, Tomita Y, Yuno A, Trepel JB, Lee S, Steinberg SM, Gulley JL, Figg WD, Dahut WL. BJU Int. 2021 Apr;127(4):435-444. doi: 10.1111/bju.15227. Epub 2020 Oct 23. PMID: 32969563; PMCID: PMC8265825.
45. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group. Magnuson A, Bruinooge SS, Singh H, Wilner KD, Jalal S, Lichtman SM, Kluetz PG, Lyman GH, Klepin HD, Fleury ME, Hirsch B, Melemed A, Arnaldez FI, Basu Roy U, Schenkel C, Sherwood S, Garrett-Mayer E. Clin Cancer Res. 2021 May 1;27(9):2424-2429. doi: 10.1158/1078-0432.CCR-20-3868. Epub 2021 Feb 9. PMID: 33563633; PMCID: PMC8102305.
46. FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors. Marcus L, Donoghue M, Aungst S, Myers CE, Helms WS, Shen G, Zhao H, Stephens O, Keegan P, Pazdur R. Clin Cancer Res. 2021 Feb 15;27(4):928-932. doi: 10.1158/1078-0432.CCR-20-2771. Epub 2020 Sep 23. PMID: 32967940.
47. FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors. Marcus L, Fashoyin-Aje LA, Donoghue M, Yuan M, Rodriguez L, Gallagher PS, Philip R, Ghosh S, Theoret MR, Beaver JA, Pazdur R, Lemery SJ. Clin Cancer Res. 2021 Sep 1;27(17):4685-4689. doi: 10.1158/1078-0432.CCR-21-0327. Epub 2021 Jun 3. PMID: 34083238; PMCID: PMC8416776.
48. Evaluating Cancer Drugs in Patients With Central Nervous System Metastases. Marur S, Beaver JA, Pazdur R. JAMA Oncol. 2021 Apr 15. doi: 10.1001/jamaoncol.2021.0180. Epub ahead of print. PMID: 33856413.
49. Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer. Mason J, Gong Y, Amiri-Kordestani L, Wedam S, Gao JJ, Prowell TM, Singh H, Amatya A, Tang S, Pazdur R, Kuhn P, Blumenthal GM, Beaver JA. JCO Clin Cancer Inform. 2021 Jun;5:758-767. doi: 10.1200/CCI.21.00025. PMID: 34297598.
50. FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations. Mathieu LN, Larkins E, Akinboro O, Roy P, Amatya AK, Fiero MH, Mishra-Kalyani PS, Helms WS, Myers CE, Skinner AM, Aungst S, Jin R, Zhao H, Xia H, Zirkelbach JF, Bi Y, Li Y, Liu J, Grimstein M, Zhang X, Woods S, Reece K, Abukhdeir AM, Ghosh S, Philip R, Tang S, Goldberg KB, Pazdur R, Beaver JA, Singh H. Clin Cancer Res. 2021 Aug 3. doi: 10.1158/1078-0432.CCR-21-1566. Epub ahead of print. PMID: 34344795.
51. FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer. Mathieu L, Shah S, Pai-Scherf L, Larkins E, Vallejo J, Li X, Rodriguez L, Mishra-Kalyani P, Goldberg KB, Kluetz PG, Theoret MR, Beaver JA, Pazdur R, Singh H. Oncologist. 2021 May;26(5):433-438. doi: 10.1002/onco.13752. Epub 2021 Mar 25. PMID: 33687763; PMCID: PMC8100557.
52. US Food and Drug Administration regulatory updates in neuro-oncology. Mehta GU, Barone AK, Bradford D, Larkins E, Kim J, Pai-Scherf L, Jaigirdar A, Shah M, Wedam S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA, Singh H. J Neurooncol. 2021 Jul;153(3):375-381. doi: 10.1007/s11060-021-03789-5. Epub 2021 Jun 22. PMID: 34156585; PMCID: PMC8218275.
53. Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration-Melanoma Research Alliance Public Workshop. Mueller KL, Theoret MR, Lemery SJ, Amiri-Kordestani L, Ariyan CE, Atkins MB, Berry DA, Blank CU, DeMichele AM, Forde PM, Ibrahim N, Keegan P, Mitchell TC, Moss RA, Robert C, Sridhara R, Taube JM, Tetzlaff MT, Wargo JA, Flaherty KT, Kaplan MJ, Topalian SL, Ward AF, Hurlbert MS. Clin Cancer Res. 2021 Jan 15;27(2):394-401. doi: 10.1158/1078-0432.CCR-20-3285. Epub 2020 Nov 13. PMID: 33188142.
54. Floor and ceiling effects in the EORTC QLQ-C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer. Murugappan MN, King-Kallimanis BL, Mangir C, Howie L, Bhatnagar V, Beaver JA, Basch EM, Henson SR, Kluetz PG. Cancer. 2021 Oct 11. doi: 10.1002/cncr.33959. Epub ahead of print. PMID: 34634139.
55. Patient Reported Outcomes in Pediatric Cancer Registration Trials: A U.S. Food and Drug Administration Perspective. Murugappan MN, King-Kallimanis BL, Reaman GH, Bhatnagar V, Horodniceanu EG, Bouchkouj N, Kluetz PG. J Natl Cancer Inst. 2021 Apr 30:djab087. doi: 10.1093/jnci/djab087. Epub ahead of print. PMID: 33930159.
56. FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma. Nair A, Reece K, Donoghue MB, Yuan WV, Rodriguez L, Keegan P, Pazdur R. Oncologist. 2021 Mar;26(3):e484-e491. doi: 10.1002/onco.13566. Epub 2020 Nov 10. PMID: 33044793; PMCID: PMC7930400.
57. FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma. Nakajima EC, Vellanki PJ, Larkins E, Chatterjee S, Mishra-Kalyani PS, Bi Y, Qosa H, Liu J, Zhao H, Biable M, Hotaki LT, Shen YL, Pazdur R, Beaver JA, Singh H, Donoghue M. Clin Cancer Res. 2021 Aug 30. doi: 10.1158/1078-0432.CCR-21-1466. Epub ahead of print. PMID: 34462287.
58. FDA Approval Summary: Sotorasib for KRAS G12C Mutated Metastatic NSCLC. Nakajima EC, Drezner N, Li X, Mishra-Kalyani PS, Liu Y, Zhao H, Bi Y, Liu J, Rahman A, Wearne E, Ojofeitimi I, Hotaki LT, Spillman D, Pazdur R, Beaver JA, Singh H. Clin Cancer Res. 2021 Dec 13:clincanres.3074.2021. doi: 10.1158/1078-0432.CCR-21-3074. Epub ahead of print. PMID: 34903582.
59. FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer. Narayan P, Osgood CL, Singh H, Chiu HJ, Ricks TK, Chiu Yuen Chow E, Qiu J, Song P, Yu J, Namuswe F, Guiterrez-Lugo M, Hou S, Pierce WF, Goldberg KB, Tang S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA. Clin Cancer Res. 2021 Aug 15;27(16):4478-4485. doi: 10.1158/1078-0432.CCR-20-4557. Epub 2021 Mar 22. PMID: 33753456; PMCID: PMC8570919.
60. FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer. Narayan P, Prowell TM, Gao JJ, Fernandes LL, Li E, Jiang X, Qiu J, Fan J, Song P, Yu J, Zhang X, King-Kallimanis BL, Chen W, Ricks TK, Gong Y, Wang X, Windsor K, Rhieu SY, Geiser G, Banerjee A, Chen X, Reyes Turcu F, Chatterjee DK, Pathak A, Seidman J, Ghosh S, Philip R, Goldberg KB, Kluetz PG, Tang S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA. Clin Cancer Res. 2021 Apr 1;27(7):1842-1849. doi: 10.1158/1078-0432.CCR-20-3652. Epub 2020 Nov 9. PMID: 33168657; PMCID: PMC8535764.
61. Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses. Norsworthy KJ, Gao X, Ko CW, Pulte ED, Zhou J, Gong Y, Shen YL, Vallejo J, Gwise TE, Sridhara R, Deisseroth AB, Farrell AT, de Claro RA, Blumenthal GM, Pazdur R. J Clin Oncol. 2021 Dec 10:JCO2101548. doi: 10.1200/JCO.21.01548. Epub ahead of print. PMID: 34890212.
62. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Prior Therapies Work Group. Osarogiagbon RU, Vega DM, Fashoyin-Aje L, Wedam S, Ison G, Atienza S, De Porre P, Biswas T, Holloway JN, Hong DS, Wempe MM, Schilsky RL, Kim ES, Wade JL 3rd. Clin Cancer Res. 2021 May 1;27(9):2408-2415. doi: 10.1158/1078-0432.CCR-20-3854. Epub 2021 Feb 9. PMID: 33563637; PMCID: PMC8170959.
63. FDA and Its Role in Drug Development. Pazdur R. J Adv Pract Oncol. 2021 Apr;12(3):293-295. doi: 10.6004/jadpro.2021.12.3.15. Epub 2021 Apr 1. PMID: 34084578; PMCID: PMC8087239.
64. Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy. Pelosof L, Saung MT, Donoghue M, Casak S, Mushti S, Cheng J, Jiang X, Liu J, Zhao H, Khazraee M, Goldberg KB, Theoret M, Lemery S, Pazdur R, Fashoyin-Aje L. Oncologist. 2021 Apr;26(4):318-324. doi: 10.1002/onco.13646. Epub 2021 Jan 11. PMID: 33345396; PMCID: PMC8018317.
65. Treatment-related toxicity and improved outcome from immunotherapy in hepatocellular cancer: Evidence from an FDA pooled analysis of landmark clinical trials with validation from routine practice. Pinato DJ, Marron TU, Mishra-Kalyani PS, Gong Y, Wei G, Szafron D, Sharon E, Saeed A, Jun T, Dharmapuri S, Naqash AR, Peeraphatdit T, Gampa A, Wang Y, Khan U, Muzaffar M, Navaid M, Lee CJ, Lee PC, Bulumulle A, Yu B, Paul S, Nimkar N, Bettinger D, Hildebrand H, Abugabal YI, Pressiani T, Personeni N, D'Alessio A, Kaseb AO, Huang YH, Ang C, Schneider J, Pillai A, Rimassa L, Goldberg KB, Pazdur R, Theoret M, Lemery S, Fashoyin-Aje ', Cortellini A, Pelosof L. Eur J Cancer. 2021 Nov;157:140-152. doi: 10.1016/j.ejca.2021.08.020. Epub 2021 Sep 8. PMID: 34508996.
66. Project 2025: Proposals for the Continued Success of Drug Development in Acute Myeloid Leukemia. Pollyea DA, Barrett J, DiNardo CD, Michaelis LC, Roboz GJ, Le RQ, Norsworthy KJ, de Claro RA, Theoret MR, Pazdur R. Clin Cancer Res. 2021 Nov 9:clincanres.2124.2021. doi: 10.1158/1078-0432.CCR-21-2124. Epub ahead of print. PMID: 34753779.
67. The Role of Acute Myeloid Leukemia Minimal Residual Disease in Regulatory Decision-making. Przepiorka D, de Claro RA, Pazdur R. JAMA Oncol. 2021 May 1;7(5):784. doi: 10.1001/jamaoncol.2021.0122. PMID: 33764395.
68. FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation. Pulte ED, Norsworthy KJ, Wang Y, Xu Q, Qosa H, Gudi R, Przepiorka D, Fu W, Okusanya OO, Goldberg KB, De Claro RA, Farrell AT, Pazdur R. Clin Cancer Res. 2021 Jul 1;27(13):3515-3521. doi: 10.1158/1078-0432.CCR-20-4271. Epub 2021 Feb 25. PMID: 33632926; PMCID: PMC8506653.
69. FDA Approval Summary: Margetuximab plus chemotherapy for advanced or metastatic HER2-positive breast cancer. Royce M, Osgood CL, Amatya AK, Fiero MH, Chang CJG, Ricks TK, Shetty KA, Kraft J, Qiu J, Song P, Charlab R, Yu J, King KE, Rastogi A, Janelsins B, Weinberg WC, Clouse K, Borders-Hemphill V, Brown L, Gomez-Broughton C, Li Z, Nguyen TT, Qiu Z, Ly AT, Chang S, Gao T, Tu CM, King-Kallimanis B, Pierce WF, Chiang K, Lee C, Goldberg KB, Leighton JK, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. Clin Cancer Res. 2021 Dec 16:clincanres.3247.2021. doi: 10.1158/1078-0432.CCR-21-3247. Epub ahead of print. PMID: 34916216.
70. Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials. Roydhouse JK, Mishra-Kalyani PS, Bhatnagar V, Gutman R, King-Kallimanis BL, Sridhara R, Kluetz PG. Value Health. 2021 Jun;24(6):822-829. doi: 10.1016/j.jval.2020.12.015. Epub 2021 Mar 18. PMID: 34119080.
71. FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib. Saung MT, Pelosof L, Casak S, Donoghue M, Lemery S, Yuan M, Rodriguez L, Schotland P, Chuk M, Davis G, Goldberg KB, Theoret MR, Pazdur R, Fashoyin-Aje L. Oncologist. 2021 Sep;26(9):797-806. doi: 10.1002/onco.13819. Epub 2021 Jun 10. PMID: 33973307; PMCID: PMC8417871.
72. Oncology Expanded Access and FDA's Project Facilitate. Scepura B, Chan M, Kim T, Boehmer J, Goldberg KB, Pazdur R. Oncologist. 2021 Oct;26(10):e1880-e1882. doi: 10.1002/onco.13910. Epub 2021 Aug 11. PMID: 34288259; PMCID: PMC8488788.
73. The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology. Schneider JA, Gong Y, Goldberg KB, Kluetz PG, Theoret MR, Amiri-Kordestani L, Beaver JA, Fashoyin-Aje L, Gormley NJ, Jaigirdar AA, Lemery SJ, Mishra-Kalyani PS, Reaman GH, Rivera DR, Rubinstein WS, Singh H, Sridhara R, Pazdur R. Clin Cancer Res. 2021 Apr 28:10.1158/1078-0432.CCR-20-4429. doi: 10.1158/1078-0432.CCR-20-4429. Epub ahead of print. PMID: 33910935; PMCID: PMC8551300.
74. The Oncology Center of Excellence Encourages Submissions of Applied Regulatory Science Research Proposals. Schneider JA, Gao JJ, Rivera DR, Donoghue MB, Reaman GH, Sridhara R, Beaver JA, Kluetz PG, Theoret MR, Pazdur R. The ASCO Post. 2021, Dec 25.
75. The Drug-Dosing Conundrum in Oncology - When Less Is More. Shah M, Rahman A, Theoret MR, Pazdur R. N Engl J Med. 2021 Oct 14;385(16):1445-1447. doi: 10.1056/NEJMp2109826. Epub 2021 Oct 9. PMID: 34623789.
76. FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer. Shah M, Wedam S, Cheng J, Fiero MH, Xia H, Li F, Fan J, Zhang X, Yu J, Song P, Chen W, Ricks TK, Chen XH, Goldberg KB, Gong Y, Pierce WF, Tang S, Theoret MR, Pazdur R, Amiri-Kordestani L, Beaver JA. Clin Cancer Res. 2021 Mar 1;27(5):1220-1226. doi: 10.1158/1078-0432.CCR-20-2701. Epub 2020 Oct 14. PMID: 33055172.
77. Immunotherapy for Patients With Small-Cell Lung Cancer-2 Gains, 2 Losses. Singh H, Beaver JA, Pazdur R. JAMA Oncol. 2021 Oct 28. doi: 10.1001/jamaoncol.2021.4956. Epub ahead of print. PMID: 34709353.
78. >Contribution of Early Clinical Benefit End Points to Decreased Lung Cancer Mortality Rates. Singh H, Pazdur R. JAMA Oncol. 2021 Jun 1;7(6):829-830. doi: 10.1001/jamaoncol.2020.8090. PMID: 33630046.
79. FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer. Singh S, Jaigirdar AA, Mulkey F, Cheng J, Hamed SS, Li Y, Liu J, Zhao H, Goheer A, Helms WS, Wang X, Agarwal R, Pragani R, Korsah K, Tang S, Leighton J, Rahman A, Beaver JA, Pazdur R, Theoret MR, Singh H. Clin Cancer Res. 2021 May 1;27(9):2378-2382. doi: 10.1158/1078-0432.CCR-20-3901. Epub 2020 Dec 7. PMID: 33288660.
80. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group. Spira AI, Stewart MD, Jones S, Chang E, Fielding A, Richie N, Wood LS, Thompson MA, Jones L, Nair A, Mahal BA, Gerber DE. Clin Cancer Res. 2021 May 1;27(9):2416-2423. doi: 10.1158/1078-0432.CCR-20-3853. Epub 2021 Feb 9. PMID: 33563636; PMCID: PMC8102342.
81. Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0. Tolaney SM, Garrett-Mayer E, White J, Blinder VS, Foster JC, Amiri-Kordestani L, Hwang ES, Bliss JM, Rakovitch E, Perlmutter J, Spears PA, Frank E, Tung NM, Elias AD, Cameron D, Denduluri N, Best AF, DiLeo A, Baizer L, Butler LP, Schwartz E, Winer EP, Korde LA. J Clin Oncol. 2021 Aug 20;39(24):2720-2731. doi: 10.1200/JCO.20.03613. Epub 2021 May 18. PMID: 34003702.
82. FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review. Vellanki PJ, Mulkey F, Jaigirdar AA, Rodriguez L, Wang Y, Xu Y, Zhao H, Liu J, Howe G, Wang J, Choo Q, Golding SJ, Mansell V, Korsah K, Spillman D, de Claro RA, Pazdur R, Beaver JA, Singh H. Clin Cancer Res. 2021 Jul 1;27(13):3522-3527. doi: 10.1158/1078-0432.CCR-20-4338. Epub 2021 Feb 25. PMID: 33632925; PMCID: PMC8254731.
83. Perspectives on Drug Development in Multiple Myeloma-Looking Forward to 2025. Voorhees PM, Jakubowiak AJ, Kumar SK, Kanapuru B, Baines AC, Bhatnagar V, Ershler R, Theoret MR, Gormley NJ, Pazdur R. Clin Cancer Res. 2021 Jul 27. doi: 10.1158/1078-0432.CCR-21-1069. Epub ahead of print. PMID: 34315721.
84. FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer. Wahby S, Fashoyin-Aje L, Osgood CL, Cheng J, Fiero MH, Zhang L, Tang S, Hamed SS, Song P, Charlab R, Dorff SE, Ricks TK, Barnett-Ringgold K, Dinin J, Goldberg KB, Theoret MR, Pazdur R, Amiri-Kordestani L, Beaver JA. Clin Cancer Res. 2021 Apr 1;27(7):1850-1854. doi: 10.1158/1078-0432.CCR-20-3119. Epub 2020 Nov 9. PMID: 33168656.
85. Toward best practice in cancer mutation detection with whole-genome and whole-exome sequencing. Xiao W, Ren L, Chen Z, Fang LT, Zhao Y, Lack J, Guan M, Zhu B, Jaeger E, Kerrigan L, Blomquist TM, Hung T, Sultan M, Idler K, Lu C, Scherer A, Kusko R, Moos M, Xiao C, Sherry ST, Abaan OD, Chen W, Chen X, Nordlund J, Liljedahl U, Maestro R, Polano M, Drabek J, Vojta P, Kõks S, Reimann E, Madala BS, Mercer T, Miller C, Jacob H, Truong T, Moshrefi A, Natarajan A, Granat A, Schroth GP, Kalamegham R, Peters E, Petitjean V, Walton A, Shen TW, Talsania K, Vera CJ, Langenbach K, de Mars M, Hipp JA, Willey JC, Wang J, Shetty J, Kriga Y, Raziuddin A, Tran B, Zheng Y, Yu Y, Cam M, Jailwala P, Nguyen C, Meerzaman D, Chen Q, Yan C, Ernest B, Mehra U, Jensen RV, Jones W, Li JL, Papas BN, Pirooznia M, Chen YC, Seifuddin F, Li Z, Liu X, Resch W, Wang J, Wu L, Yavas G, Miles C, Ning B, Tong W, Mason CE, Donaldson E, Lababidi S, Staudt LM, Tezak Z, Hong H, Wang C, Shi L. Nat Biotechnol. 2021 Sep;39(9):1141-1150. doi: 10.1038/s41587-021-00994-5. Epub 2021 Sep 9. PMID: 34504346; PMCID: PMC8506910.
86. Whole genome and exome sequencing reference datasets from a multi-center and cross-platform benchmark study. Zhao Y, Fang LT, Shen TW, Choudhari S, Talsania K, Chen X, Shetty J, Kriga Y, Tran B, Zhu B, Chen Z, Chen W, Wang C, Jaeger E, Meerzaman D, Lu C, Idler K, Ren L, Zheng Y, Shi L, Petitjean V, Sultan M, Hung T, Peters E, Drabek J, Vojta P, Maestro R, Gasparotto D, Kõks S, Reimann E, Scherer A, Nordlund J, Liljedahl U, Foox J, Mason CE, Xiao C, Hong H, Xiao W. Sci Data. 2021 Nov 9;8(1):296. doi: 10.1038/s41597-021-01077-5. PMID: 34753956; PMCID: PMC8578599.

2020

1. Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development. Ahmed MA, Patel C, Drezner N, Helms W, Tan W, Stypinski D. Clin Transl Sci. 2020 Jan;13(1):31-40. doi: 10.1111/cts.12703.
2. A review of the experience with pediatric written requests issued for oncology drug products. Akalu AY, Meng X, Reaman GH, Ma L, Yuan W, Ye J. Pediatr Blood Cancer. 2020 Nov 27:e28828. doi: 10.1002/pbc.28828.
3. Public-private partnerships in transplant drug development. Albrecht R, Papadopoulos EJ, Campbell M, Daniels S, Kluetz PG, Parekh A, Wang Y. Am J Transplant. 2020 Feb;20(2):377-381. doi: 10.1111/ajt.15604.
4. An FDA Analysis of Survival Outcomes Comparing an Adjuvant Paclitaxel and Trastuzumab Trial to an External Control from Historical Clinical Trials. Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. Ann Oncol. 2020 Aug 28:S0923-7534(20)42171-4. doi: 10.1016/j.annonc.2020.08.2106.
5. FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA-Mutated Metastatic Castrate-Resistant Prostate Cancer. Anscher MS, Chang E, Gao X, Gong Y, Weinstock C, Bloomquist E, Adeniyi O, Charlab R, Zimmerman S, Serlemitsos-Day M, Ning YM, Mayrosh R, Fuller B, Trentacosti AM, Gallagher P, Bijwaard K, Philip R, Ghosh S, Fahnbulleh F, Diggs F, Arora S, Goldberg KB, Tang S, Amiri-Kordestani L, Pazdur R, Ibrahim A, Beaver JA. Oncologist. 2020 Nov 4. doi: 10.1002/onco.13585.
6. FDA Approval Summary: Olaparib monotherapy or in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer. Arora S, Balasubramaniam S, Zhang H, Berman T, Narayan P, Suzman D, Bloomquist E, Tang S, Gong Y, Sridhara R, Turcu FR, Chatterjee D, Saritas-Yildirim B, Ghosh S, Philip R, Pathak A, Gao JJ, Amiri-Kordestani L, Pazdur R, Beaver JA. Oncologist. 2020 Oct 5. doi: 10.1002/onco.13551.
7. FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis. Arora S, Balasubramaniam S, Zhang W, Zhang L, Sridhara R, Spillman D, Mathai JP, Scott B, Golding SJ, Coory M, Pazdur R, Beaver JA. Clin Cancer Res. 2020 Oct 1;26(19):5062-5067. doi: 10.1158/1078-0432.CCR-19-3979.
8. Update on Data Required to Build a Learning Health System. Bertagnolli MM, Anderson B, Norsworthy K, Piantadosi S, Quina A, Schilsky RL, Miller RS, Khozin S. J Clin Oncol. 2020 May 10;38(14):1602-1607. doi: 10.1200/JCO.19.03094.
9. Patient-Reported Outcomes in Oncology Clinical Trials: Stakeholder Perspectives from the Accelerating Anticancer Agent Development and Validation Workshop 2019. Bhatnagar V, Hudgens S, Piault-Louis E, Jones L, Beaver JA, Lyerly HK, Reaman G, Fleming T, Kluetz PG. Oncologist. 2020 May 28. doi: 10.1634/theoncologist.2020-0062.
10. Idelalisib for Treatment of Relapsed Follicular Lymphoma and Chronic Lymphocytic Leukemia: A Comparison of Treatment Outcomes in Clinical Trial Participants vs Medicare Beneficiaries. Bird ST, Tian F, Flowers N, Przepiorka D, Wang R, Jung TH, Kessler Z, Woods C, Kim B, Miller BW, Wernecke M, Kim C, McKean S, Gelperin K, MaCurdy TE, Kelman JA, Graham DJ. JAMA Oncol. 2020 Feb 1;6(2):248-254. doi: 10.1001/jamaoncol.2019.3994.
11. An Empirical Investigation of Bayesian Clinical Trial Design in Metastatic Breast Cancer. Bloomquist E, Jin S, Zhou J, Tang S, Sridhara R. Ther Innov Regul Sci. 2020 Jul;54(4):861-869. doi: 10.1007/s43441-019-00002-8.
12. Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer. Bonomi P, Stuccio N, Delgra CJ, Chuk MK, Spira A, Deitz AC, Blumenthal GM, Ferris A, Gong Y, He J, Basu Roy U, Selig W. Ther Innov Regul Sci. 2020 Sep;54(5):1208-1214. doi: 10.1007/s43441-020-00145-z.
13. FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma. Bradford D, Demko S, Jin S, Mishra-Kalyani P, Beckles AR, Goldberg KB, Lemery S, Ward A, Keegan P, Pazdur R. Oncologist. 2020 Jul;25(7):e1077-e1082. doi: 10.1634/theoncologist.2020-0184.
14. FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid cancers with RET Gene Mutations or Fusions. Bradford D, Larkins E, Mushti SL, Rodriguez L, Skinner AM, Helms WS, Price LSL, Fourie Zirkelbach J, Li Y, Liu J, Charlab R, Reyes Turcu F, Liang D, Ghosh S, Roscoe D, Philip R, Zack-Taylor A, Tang S, Kluetz PG, Beaver JA, Pazdur R, Theoret MR, Singh H. Clin Cancer Res. 2020 Nov 25:clincanres.3558.2020. doi: 10.1158/1078-0432.CCR-20-3558.
15. An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer. Brave M, Weinstock C, Brewer JR, Chi DC, Suzman DL, Cheng J, Zhang L, Sridhara R, Ibrahim A, Kluetz PG, Pazdur R, Beaver JA. Clin Cancer Res. 2020 Sep 15;26(18):4717-4722. doi: 10.1158/1078-0432.CCR-19-3835.
16. Regulatory Considerations for Contribution of Effect of Drugs used in Combination Regimens: Renal Cell Cancer Case Studies. Brewer JR, Chang E, Agrawal S, Singh H, Suzman DL, Xu J, Weinstock C, Fernandes LL, Cheng J, Zhang L, Xie D, Goldberg KB, Bloomquist EW, Tang S, Sridhara R, Theoret MR, Pazdur R, Ibrahim A, Beaver JA. Clin Cancer Res. 2020 Jul 30:clincanres.4229.2020. doi: 10.1158/1078-0432.CCR-19-4229.
17. Disparities in Cancer Prevention in the COVID-19 Era. Carethers JM, Sengupta R, Blakey R, Ribas A, D'Souza G. Cancer Prev Res (Phila). 2020 Sep 17. doi: 10.1158/1940-6207.CAPR-20-0447.
18. FDA Approval Summary: Atezolizumab plus bevacizumab for the treatment of patients with advanced unresectable or metastatic hepatocellular carcinoma. Casak SJ, Donoghue M, Fashoyin-Aje L, Jiang X, Rodriguez L, Shen YL, Xu Y, Jiang X, Liu J, Zhao H, Pierce WF, Mehta S, Goldberg KB, Theoret MR, Kluetz PG, Pazdur R, Lemery SJ. Clin Cancer Res. 2020 Nov 2:clincanres.3407.2020. doi: 10.1158/1078-0432.CCR-20-3407.
19. FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma. Chang E, Weinstock C, Zhang L, Charlab R, Dorff SE, Gong Y, Hsu V, Li F, Ricks TK, Song P, Tang S, Waldron PE, Yu J, Zahalka E, Goldberg KB, Pazdur R, Theoret MR, Ibrahim A, Beaver JA. Clin Cancer Res. 2020 Sep 22:clincanres.2275.2020. doi: 10.1158/1078-0432.CCR-20-2275.
20. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. Coens C, Pe M, Dueck AC, Sloan J, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro JZ, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Bottomley A. Lancet Oncol. 2020 Feb;21(2):e83-e96. doi: 10.1016/S1470-2045(19)30790-9.
21. U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program. de Claro RA, Gao JJ, Kim T, Kluetz PG, Theoret MR, Beaver JA, Pazdur R. Clin Cancer Res. 2020 Aug 19:clincanres.2220.2020. doi: 10.1158/1078-0432.CCR-20-2220.
22. Project Orbis: Global Collaborative Review Program. de Claro RA, Spillman D, Hotaki LT, Shum M, Mouawad LS, Santos GML, Robinson K, Hunt M, Healy C, Chan A, Looi YH, Rodrigues C, Rohr UP, Walther C, Pazdur R. Clin Cancer Res. 2020 Oct 9. doi: 10.1158/1078-0432.CCR-20-3292.
23. Hemophilia prophylaxis adherence and bleeding using a tailored, frequency-escalated approach: The Canadian Hemophilia Primary Prophylaxis Study. Dover S, Blanchette VS, Wrathall D, Pullenayegum E, Kazandjian D, Song B, Hawes SA, Cloutier S, Rivard GE, Klaassen RJ, Paradis E, Laferriere N, Stain AM, Chan AK, Israels SJ, Sinha R, Steele M, Wu JKM, Feldman BM. Res Pract Thromb Haemost. 2020 Jan 29;4(2):318-325. doi: 10.1002/rth2.12301. PMID: 32110763.
24. Weighty choices: selecting optimal G-CSF doses for stem cell mobilization to optimize yield. Farhadfar N, Hsu JW, Logan BR, Sees JA, Chitphakdithai P, Sugrue MW, Abdel-Azim H, Anderlini PN, Bredeson C, Chhabra S, Diaz MA, Ganguly S, Hematti P, Kamble RT, Kasow KA, Lazarus HM, Lynch DK, Murthy HS, Olsson RF, Papari M, Przepiorka D, Savani BN, Schears R, Seo S, Solh MM, Spitzer T, Yared JA, Pulsipher MA, Shah NN, Switzer GE, Confer DL, Shaw BE, Wingard JR. Blood Adv. 2020 Feb 25;4(4):706-716. doi: 10.1182/bloodadvances.2019000923.
25. Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases. Febbo PG, Martin AM, Scher HI, Barrett JC, Beaver JA, Beresford PJ, Blumenthal GM, Bramlett K, Compton C, Dittamore R, Eberhard DA, Edelstein D, Godsey J, Gruen A, Hanlon SE, Hicks J, Hovelson D, Hullings M, Johann D, Johnson J, Kolatkar A, Kuhn P, Levine R, Martini JF, Miller DP, Moore C, Moy B, Pathak A, Philip R, Reese D, Royalty W, Ryder M, Sakul H, Salvatore LM, Schade A, Silvestro A, Simmons JK, Simons J, Singh Bhan S, Smalley MD, Somiari SB, Talasaz A, Tewari M, Tseng HR, Vinson J, Wells W, Welsh A, Grossman RL, Lee JSH, Leiman LC. Clin Pharmacol Ther. 2020 Apr;107(4):730-734. doi: 10.1002/cpt.1747.
26. Demystifying the estimand framework: a case study using patient-reported outcomes in oncology. Fiero MH, Pe M, Weinstock C, King-Kallimanis BL, Komo S, Klepin HD, Gray SW, Bottomley A, Kluetz PG, Sridhara R. Lancet Oncol. 2020 Oct;21(10):e488-e494. doi: 10.1016/S1470-2045(20)30319-3.
27. US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January 2008 and December 2017. Fiero MH, Roydhouse JK, Vallejo J, King-Kallimanis BL, Kluetz PG, Sridhara R. Lancet Oncol. 2019 Oct;20(10):e582-e589. doi: 10.1016/S1470-2045(19)30335-3.
28. The RACE to Develop New Targeted Therapies for Children With CNS Tumors. Fletcher EP, Burckart GJ, Robinson GW, Reaman GH, Stewart CF. Clin Pharmacol Ther. 2020 Jul 7. doi: 10.1002/cpt.1937.
29. Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria: Perspectives of a Multistakeholder Working Group. Forde PM, Bonomi P, Shaw A, Blumenthal GM, Ferris A, Patel C, Melemed A, Basu Roy U, Ramamoorthy A, Liu Q, Burns T, Gainor JF, Lovly C, Piotrowska Z, Lehman J, Selig W. Clin Lung Cancer. 2020 Jul;21(4):295-307. doi: 10.1016/j.cllc.2020.02.008.
30. Ethnicity-based differences in breast cancer features and responsiveness to CDK4/6 inhibitors combined with endocrine therapy - Authors' reply. Gao JJ, Cheng J, Beaver JA, Prowell TM. Lancet Oncol. 2020 Mar;21(3):e131. doi: 10.1016/S1470-2045(20)30095-4.
31. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Gao JJ, Cheng J, Bloomquist E, Sanchez J, Wedam SB, Singh H, Amiri-Kordestani L, Ibrahim A, Sridhara R, Goldberg KB, Theoret MR, Kluetz PG, Blumenthal GM, Pazdur R, Beaver JA, Prowell TM. Lancet Oncol. 2020 Feb;21(2):250-260. doi: 10.1016/S1470-2045(19)30804-6.
32. Engaging the Oncology Community to Advanced Regulatory Science – FDA’s Project Renewal and Project Socrates. Gao JJ, Keegan P, Kluetz P, Pazdur R. AACR Cancer Research Catalyst. July 28, 2020.
33. FDA Oncology Center of Excellence Review Processes and Tools. Gao JJ, Kluetz PG, Pazdur R. Clin Pharmacol Ther. 2020 Jul 12. doi: 10.1002/cpt.1945.
34. FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf injection for subcutaneous use in Patients with HER2-Positive Breast Cancer. Gao JJ, Osgood CL, Gong Y, Zhang H, Bloomquist EW, Jiang X, Qiu J, Yu J, Song P, Rahman A, Chiu HJ, Ricks TK, Rizvi F, Hou S, Wilson W, Abukhdeir AM, Seidman J, Ghosh S, Philip R, Pierce WF, Bhatnagar V, Kluetz PG, Pazdur R, Beaver JA, Amiri-Kordestani L. Clin Cancer Res. 2020 Nov 13:clincanres.3474.2020. doi: 10.1158/1078-0432.CCR-20-3474.
35. FDA Oncology Center of Excellence During COVID-19-Working for Patients With Cancer. Gao JJ, Pazdur R. FDA Oncology Center of Excellence During COVID-19-Working for Patients With Cancer. JAMA Oncol. 2020 Dec 23. doi: 10.1001/jamaoncol.2020.6783.
36. Before It's Too Late: Multistakeholder Perspectives on Compassionate Access to Investigational Drugs for Pediatric Patients With Cancer. Gerasimov E, Donoghue M, Bilenker J, Watt T, Goodman N, Laetsch TW. Am Soc Clin Oncol Educ Book. 2020 May;40:1-10. doi: 10.1200/EDBK_278995. PMID: 32412804.
37. Novel Therapeutic Interventions Early in the Disease Trajectory: Drug Development Beyond the Refractory Setting. Hafez N, Rugo HS, Tempero MA, Fox E, Reaman GH, Lyerly HK, Walker D, LoRusso PM. Clin Cancer Res. 2020 Sep 15;26(18):4743-4747. doi: 10.1158/1078-0432.CCR-19-4035.
38. Assessment of Discordance Among Smoldering Multiple Myeloma Risk Models. Hill E, Dew A, Morrison C, Yuan C, Stetler-Stevenson M, Landgren O, Kazandjian D. JAMA Oncol. 2020 Nov 19:e205585. doi: 10.1001/jamaoncol.2020.5585.
39. Diagnostic performance of 18F‐FDG‐PET/CT compared to standard skeletal survey for detecting bone destruction in smouldering multiple myeloma: time to move forward. Hill, E., Mena, E., Morrison, C., Dew, A., Choyke, P., Lindenberg, L. and Kazandjian, D. (2020), Br J Haematol. 2020 Sep 23. doi: 10.1111/bjh.17088.
40. Summary of the 2019 Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling. Holstein SA, Howard A, Avigan D, Bhutani M, Cohen AD, Costa LJ, Dhodapkar MV, Gay F, Gormley N, Green DJ, Hillengass J, Korde N, Li Z, Mailankody S, Neri P, Parekh S, Pasquini MC, Puig N, Roodman GD, Samur MK, Shah N, Shah UA, Shi Q, Spencer A, Suman VJ, Usmani SZ, McCarthy PL. Biol Blood Marrow Transplant. 2020 Oct;26(10):e247-e255. doi: 10.1016/j.bbmt.2020.06.011.
41. US Food and Drug Administration Support for Oncology Drug Development During COVID-19. Kadakia KT, Pazdur R, Shah A. JAMA Oncol. 2020 Oct 8. doi: 10.1001/jamaoncol.2020.4975.
42. Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation. Kanapuru B, Singh H, Kwitkowski V, Blumenthal G, Farrell AT, Pazdur R. Blood Rev. 2020 Sep;43:100670. doi: 10.1016/j.blre.2020.100670.
43. The Globalization of Geriatric Oncology: From Data to Practice. Kanesvaran R, Mohile S, Soto-Perez-de-Celis E, Singh H. Am Soc Clin Oncol Educ Book. 2020 Mar;40:1-9. doi: 10.1200/EDBK_279513. PMID: 32347757.
44. The changing role of high dose melphalan with stem cell rescue in the treatment of newly diagnosed multiple myeloma in the era of modern therapies-back to the future! Kazandjian D, Dew A, Hill E. Best Pract Res Clin Haematol. 2020 Mar;33(1):101150. doi: 10.1016/j.beha.2020.101150.
45. Application of the Lung Immune Prognostic Index From Research to Clinical Practice-Reply. Kazandjian D, Gong Y, Blumenthal GM. JAMA Oncol. 2020 Feb 1;6(2):300-301. doi: 10.1001/jamaoncol.2019.5157.
46. The role of high-dose melphalan with autologous stem-cell transplant in multiple myeloma: is it time for a paradigm shift? Kazandjian D, Mo CC, Landgren O, Richardson PG. Br J Haematol. 2020 Jun 5. doi: 10.1111/bjh.16764.
47. Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs. Kim J, Nair A, Keegan P, Beaver JA, Kluetz PG, Pazdur R, Chuk M, Blumenthal GM. Oncologist. 2020 Apr;25(4):348-354. doi: 10.1634/theoncologist.2019-0653.
48. FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease. King-Kallimanis BL, Wroblewski T, Kwitkowski V, De Claro RA, Gwise T, Bhatnagar V, Farrell AT, Kluetz PG. Qual Life Res. 2020 Jul;29(7):1903-1911. doi: 10.1007/s11136-020-02448-y.
49. FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs. Kluetz PG, Keegan P, Demetri GD, Thornton KA, Sul J, Kim J, Katzen H, Burke LB, Harvey RD, Alebachew E, Agrawal S, Nair A, Donoghue M, Pierce WF, Shord SS, Gao JJ, Pazdur R. Clin Cancer Res. 2020 Nov 30:clincanres.3213.2020. doi: 10.1158/1078-0432.CCR-20-3213.
50. Advancing Assessment, Analysis, and Reporting of Safety and Tolerability in Cancer Trials. Kluetz PG, King-Kallimanis BL, Suzman D, Chang E, Brave MM, Weinstock C, Bhatnagar V, Beaver JA, Chuk MK. J Natl Cancer Inst. 2020 Aug 28:djaa135. doi: 10.1093/jnci/djaa135.
51. Preparing Fellows for Graduation: Perspectives on Career Guidance. LaCasce A, Graff S, Gao J, Close J, Boulmay B. Am Soc Clin Oncol Educ Book. 2019 Jan;39:609-614. doi: 10.1200/EDBK_242603.
52. Treatments for newly diagnosed multiple myeloma: when endurance is interrupted. Landgren O, Siegel D, Kazandjian D, Costa L, Jakubowiak A. Lancet Oncol. 2020 Dec;21(12):e540. doi: 10.1016/S1470-2045(20)30635-5.
53. Cancer and aging activities at the American Society of Clinical Oncology and beyond: Reflections on the legacy of Dr. Arti Hurria. Levit LA, Singh H, Klepin HD. J Geriatr Oncol. 2020 Mar;11(2):151-153. doi: 10.1016/j.jgo.2019.07.007.
54. Second malignancies in multiple myeloma; emerging patterns and future directions. Maclachlan K, Diamond B, Maura F, Hillengass J, Turesson I, Landgren CO, Kazandjian D. Best Pract Res Clin Haematol. 2020 Mar;33(1):101144. doi: 10.1016/j.beha.2020.101144.
55. Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics. Manning ML, Thompson MD, Saber H, Maher VE, Crich JZ, Leighton JK. An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products. Regul Toxicol Pharmacol. 2020 Feb;110:104511. doi: 10.1016/j.yrtph.2019.104511. Kamperschroer C, Shenton J, Lebrec H, Leighton JK, Moore PA, Thomas O. J Immunotoxicol. 2020 Dec;17(1):67-85. doi: 10.1080/1547691X.2020.1729902.
56. An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products. Manning ML, Thompson MD, Saber H, Maher VE, Crich JZ, Leighton JK. Regul Toxicol Pharmacol. 2020 Feb;110:104511. doi: 10.1016/j.yrtph.2019.104511.
57. FDA Approval Summary: Entrectinib for the treatment of NTRK-gene fusion solid tumors. Marcus L, Donoghue M, Aungst S, Myers CE, Helms WS, Shen G, Zhao H, Stephens O, Keegan P, Pazdur R. Clin Cancer Res. 2020 Sep 23:clincanres.2771.2020. doi: 10.1158/1078-0432.CCR-20-2771.
58. FDA approval summary: Dalteparin for the treatment of symptomatic venous thromboembolism in pediatric patients. Merino M, Richardson N, Reaman G, Ande A, Zvada S, Liu C, Hariharan S, De Claro RA, Farrell A, Pazdur R. Pediatr Blood Cancer. 2020 Sep 8:e28688. doi: 10.1002/pbc.28688.
59. Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting. Momper JD, Heinrichs MT, Krudys K, Griebel D, Kumar S, Kim I, Mehrotra N, Mulberg AE, Garimella N, Nelson R, Reaman G, Sinha V, Yao L, Zineh I, Burckart G, Sachs H, Mulugeta Y. J Clin Pharmacol. 2020 Jun;60(6):775-784. doi: 10.1002/jcph.1577.
60. Neoadjuvant Therapy for Melanoma: A US Food and Drug Administration - Melanoma Research Alliance Public Workshop. Mueller KL, Theoret MR, Lemery SJ, Amiri-Kordestani L, Ariyan CE, Atkins MB, Berry DA, Blank CU, DeMichele A, Forde PM, Ibrahim N, Keegan P, Mitchell TC, Moss RA, Robert C, Sridhara R, Taube JM, Tetzlaff MT, Wargo JA, Flaherty K, Kaplan MJ, Topalian SL, Ward AF, Hurlbert MS. Clin Cancer Res. 2020 Nov 13:clincanres.3285.2020. doi: 10.1158/1078-0432.CCR-20-3285.
61. Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis. Mulkey F, Theoret MR, Keegan P, Pazdur R, Sridhara R. J Immunother Cancer. 2020 Feb;8(1):e000146. doi: 10.1136/jitc-2019-000146.
62. Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy. Mushti SL, Mulkey F, Tang S, Singh H, Lemery SJ, Goldberg KB, Sridhara R, Keegan P, Kluetz PG, Pazdur R, Theoret MR, Beaver JA. Curr Oncol Rep. 2020 Aug 27;22(11):116. doi: 10.1007/s11912-020-00974-z.
63. FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma. Nair A, Reece K, Donoghue MB, Yuan WV, Rodriguez L, Keegan P, Pazdur R. Oncologist. 2020 Oct 12. doi: 10.1002/onco.13566.
64. State of the Science and Future Directions for Liquid Biopsies in Drug Development. Narayan P, Ghosh S, Philip R, Barrett JC, McCormack RT, Odegaard JI, R Oxnard G, Pracht LJ, Williams PM, Kelloff GJ, Beaver JA. Oncologist. 2020 Jun 8;25(9):730–2. doi: 10.1634/theoncologist.2020-0246.
65. FDA Approval Summary: Alpelisib plus fulvestrant for patients with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer. Narayan P, Prowell TM, Gao JJ, Fernandes LL, Li E, Jiang X, Qiu J, Fan J, Song P, Yu J, Zhang X, King-Kallimanis BL, Chen W, Ricks TK, Gong Y, Wang X, Windsor K, Rhieu SY, Gieser G, Banerjee A, Chen X, Reyes Turcu F, Chatterjee DK, Pathak A, Seidman J, Ghosh S, Philip R, Goldberg KB, Kluetz PG, Tang S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA. Clin Cancer Res. 2020 Nov 9:clincanres.3652.2020. doi: 10.1158/1078-0432.CCR-20-3652.
66. FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1. Narayan P, Wahby S, Gao JJ, Amiri-Kordestani L, Ibrahim A, Bloomquist E, Tang S, Xu Y, Liu J, Fu W, Song P, King-Kallimanis BL, Hou S, Gong Y, Kalavar S, Ghosh S, Philip R, Goldberg KB, Theoret MR, Blumenthal GM, Kluetz PG, Sridhara R, Pazdur R, Beaver JA. Clin Cancer Res. 2020 May 15;26(10):2284-2289. doi: 10.1158/1078-0432.CCR-19-3545.
67. Proteasome inhibitor-associated thrombotic microangiopathy: A review of cases reported to the FDA adverse event reporting system and published in the literature. Nguyen MN, Nayernama A, Jones SC, Kanapuru B, Gormley N, Waldron PE. Am J Hematol. 2020 Apr 15. doi: 10.1002/ajh.25832.
68. Second cancers in adults with acute promyelocytic leukemia treated with or without arsenic trioxide: a SEER-Medicare analysis. Norsworthy KJ, Avagyan A, Bird ST, Li Y, Akhtar S, Liao J, Wernecke M, Deisseroth AB, Chuk M, MaCurdy TE, Swain R, Kelman JA, Farrell AT, de Claro RA, Pazdur R, Blumenthal G, Graham DJ. Leukemia. 2020 Jun 9. doi: 10.1038/s41375-020-0905-y.
69. Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis. Norsworthy KJ, Mulkey F, Scott EC, Ward AF, Przepiorka D, Charlab R, Dorff SE, Deisseroth A, Kazandjian D, Sridhara R, Beaver JA, Farrell AT, de Claro RA, Pazdur R. Clin Cancer Res. 2020 Aug 15;26(16):4280-4288. doi: 10.1158/1078-0432.CCR-20-0834.
70. BCR-ABL tyrosine kinase inhibitor-associated thyroid dysfunction: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature. Patel S, Nayernama A, Jones SC, de Claro RA, Waldron PE. Am J Hematol. 2020 Sep 11. doi: 10.1002/ajh.25997.
71. Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration. Pearson AD, Stegmaier K, Bourdeaut F, Reaman G, Heenen D, Meyers ML, Armstrong SA, Brown P, De Carvalho D, Jabado N, Marshall L, Rivera M, Smith M, Adamson PC, Barone A, Baumann C, Blackman S, Buenger V, Donoghue M, Duncan AD, Fox E, Gadbaw B, Hattersley M, Ho P, Jacobs I, Kelly MJ, Kieran M, Lesa G, Ligas F, Ludwinski D, McDonough J, Nikolova Z, Norga K, Senderowicz A, Taube T, Weiner S, Karres D, Vassal G. Eur J Cancer. 2020 Sep 25;139:135-148. doi: 10.1016/j.ejca.2020.08.014.
72. The RACE to accelerate drug development for children with cancer. Pearson ADJ, Karres D, Reaman G, DuBois SG, Knox L, Scobie N, Vassal G. Lancet Child Adolesc Health. 2020 Oct;4(10):714-716. doi: 10.1016/S2352-4642(20)30247-9.
73. ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients. Pearson ADJ, Rossig C, Lesa G, Diede SJ, Weiner S, Anderson J, Gray J, Geoerger B, Minard-Colin V, Marshall LV, Smith M, Sondel P, Bajars M, Baldazzi C, Barry E, Blackman S, Blanc P, Capdeville R, Caron H, Cole PD, Jiménez JC, Demolis P, Donoghue M, Elgadi M, Gajewski T, Galluzzo S, Ilaria R Jr, Jenkner A, Karres D, Kieran M, Ligas F, Lowy I, Meyers M, Oprea C, Peddareddigari VGR, Sterba J, Stockman PK, Suenaert P, Tabori U, van Tilburg C, Yancey T, Weigel B, Norga K, Reaman G, Vassal G. Eur J Cancer. 2020 Mar;127:52-66. doi: 10.1016/j.ejca.2019.12.029.
74. Paediatric Strategy Forum for medicinal product development for acute myeloid leukaemia in children and adolescents: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration. Pearson ADJ, Zwaan CM, Kolb EA, Karres D, Guillot J, Kim SY, Marshall L, Tasian SK, Smith M, Cooper T, Adamson PC, Barry E, Benettaib B, Binlich F, Borgman A, Brivio E, Capdeville R, Delgado D, Faller D, Fogelstrand L, Fraenkel PG, Hasle H, Heenen D, Kaspers G, Kieran M, Klusmann JH, Lesa G, Ligas F, Mappa S, Mohamed H, Moore A, Morris J, Nottage K, Reinhardt D, Scobie N, Simko S, Winkler T, Norga K, Reaman G, Vassal G. Eur J Cancer. 2020 Sep;136:116-129. doi: 10.1016/j.ejca.2020.04.038.
75. Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy. Pelosof L, Saung MT, Donoghue M, Casak S, Mushti S, Cheng J, Jiang X, Liu J, Zhao H, Khazraee M, Goldberg KB, Theoret M, Lemery S, Pazdur R, Fashoyin-Aje L. Oncologist. 2020 Dec 20. doi: 10.1002/onco.13646.
76. FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease. Przepiorka D, Luo L, Subramaniam S, Qiu J, Gudi R, Cunningham LC, Nie L, Leong R, Ma L, Sheth C, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R. Oncologist. 2020 Feb;25(2):e328-e334. doi: 10.1634/theoncologist.2019-0627.
77. Broadening Eligibility Criteria for Oncology Clinical Trials: Current Advances and Future Directions. Rahman NA, Ison G, Beaver JA. Clin Pharmacol Ther. 2020 Jul 8. doi: 10.1002/cpt.1919.
78. Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma. Raju GK, Gurumurthi K, Domike R, Singh H, Weinstock C, Kluetz P, Pazdur R, Woodcock J. Clin Pharmacol Ther. 2020 Mar;107(3):495-506. doi: 10.1002/cpt.1589.
79. Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration. Reaman G, Karres D, Ligas F, Lesa G, Casey D, Ehrlich L, Norga K, Pazdur R. J Clin Oncol. 2020 Sep 18:JCO2002152. doi: 10.1200/JCO.20.02152.
80. Crossing Oceans: Preclinical Collaboration to Improve Pediatric Drug Development. Reaman G, Stancato L, Vassal G, Maris JM. Am Soc Clin Oncol Educ Book. 2020 Mar;40:1-8. doi:10.1200/EDBK_278893.
81. Operational strategies in US cancer centers of excellence that support the successful accrual of racial and ethnic minorities in clinical trials. Regnante JM, Richie N, Fashoyin-Aje L, Hall LL, Highsmith Q, Louis J, Turner K, Hoover S, Lee SC, González E, Williams E, Adams H 3rd, Obasaju C, Sargeant I, Spinner J, Reddick C, Gandee M, Geday M, Dang J, Watson R, Chen MS Jr. Contemp Clin Trials Commun. 2020 Jan 22;17:100532. doi: 10.1016/j.conctc.2020.100532.
82. Exploration of baseline patient-reported side effect bother from cancer therapy. Roydhouse JK, King-Kallimanis BL, Roy P, Weinstock C, Krol D, Daniels SR, Suzman DL, Beaver JA, Kluetz PG. Clin Trials. 2020 Jun;17(3):332-337. doi: 10.1177/1740774520910389.
83. Concomitant botanical medicine use among patients participating in commercial prostate cancer trials. Roydhouse JK, Menapace LA, Xia H, Song P, Berman T, Agarwal R, Suzman DL, Wright K, Beaver JA, Kluetz PG. Complement Ther Med. 2020 Nov;54:102549. doi: 10.1016/j.ctim.2020.102549.
84. Antibody-Drug Conjugates: Simple Idea, Complicated Matter. Saber H, Leighton JK. DIA Global Forum. 2020 October.
85. An Analysis of Recent FDA Oncology Scientific Publications. Schneider JA, Miklos AC, Onken J, Gong Y, Calcagno AM, Blumenthal GM, Aragon R, Pazdur R. Oncologist. 2020 Mar;25(3):266-270. doi: 10.1634/theoncologist.2019-0503.
86. The Evolution of Clinical Trials in Metastatic Breast Cancer: Design Features and Endpoints That Matter. Seidman AD, Maues J, Tomlin T, Bhatnagar V, Beaver JA. Am Soc Clin Oncol Educ Book. 2020 Mar;40:1-11. doi: 10.1200/EDBK_280451.
87. FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-Positive Breast Cancer. Shah M, Wedam S, Cheng J, Fiero MH, Xia H, Li F, Fan J, Zhang X, Yu J, Song P, Chen W, Ricks TK, Chen XH, Goldberg KB, Gong Y, Pierce WF, Tang S, Theoret MR, Pazdur R, Amiri-Kordestani L, Beaver JA. Clin Cancer Res 2020 Oct 14;clincanres.2701.2020.
88. Approvals in 2019: international review and a new agnostic molecular entity. Singh H, Blumenthal G, Pazdur R. Nat Rev Clin Oncol. 2020 Mar;17(3):130-131. doi: 10.1038/s41571-020-0336-8.
89. Fatal neutropenic enterocolitis associated with docetaxel use: A review of cases reported to the United States Food and Drug Administration Adverse Event Reporting System. Singh P, Nayernama A, Christopher Jones S, Amiri Kordestani L, Fedenko K, Prowell T, Bersoff-Matcha SJ. J Oncol Pharm Pract. 2020 Jun;26(4):923-928. doi: 10.1177/1078155219879494.
90. FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer. Singh S, Jaigirdar AA, Mulkey F, Cheng J, Hamed SS, Li Y, Liu J, Zhao H, Goheer A, Helms WS, Wang X, Agarwal R, Pragani R, Korsah K, Tang S, Leighton J, Rahman A, Beaver JA, Pazdur R, Theoret MR, Singh H. Clin Cancer Res. 2020 Dec 7:clincanres.3901.2020. doi: 10.1158/1078-0432.CCR-20-3901.
91. Summary of American Statistical Association Biopharmaceutical Section’s virtual discussion with regulators on type 1 error considerations in master protocols with common control in oncology. Sridhara R, Marchenko O, Jiang Q, Pazdur R, Binkowitz B. 2020 Biopharmaceutical Report. 27;3:39-40.
92. Development, Validation, and Regulatory Considerations for a Liquid Biopsy Test. Tsui DWY, Blumenthal GM, Philip R, Barrett JC, Montagut C, Bramlett K, Ladanyi M, Ghosh S. Clin Chem. 2020 Mar 1;66(3):408-414. doi: 10.1093/clinchem/hvaa010.
93. FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third Line Treatment of Metastatic Triple-negative Breast Cancer (mTNBC). Wahby S, Fashoyin-Aje L, Osgood CL, Cheng J, Fiero MH, Zhang L, Tang S, Hamed SS, Song P, Charlab R, Dorff SE, Ricks TK, Barnett-Ringgold K, Dinin J, Goldberg KB, Theoret MR, Pazdur R, Amiri-Kordestani L, Beaver JA. Oncologist. 2021 Feb;26(2):139-146. doi: 10.1002/onco.13585. Epub 2020 Nov 17. PMID: 33145877; PMCID: PMC7873319.
94. FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer. Wedam S, Fashoyin-Aje L, Bloomquist E, Tang S, Sridhara R, Goldberg KB, Theoret MR, Amiri-Kordestani L, Pazdur R, Beaver JA. Clin Cancer Res. 2020 Mar 15;26(6):1208-1212. doi: 10.1158/1078-0432.CCR-19-2580.
95. Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer. Wedam S, Fashoyin-Aje L, Gao X, Bloomquist E, Tang S, Sridhara R, Goldberg KB, King-Kallimanis BL, Theoret MR, Ibrahim A, Amiri-Kordestani L, Pazdur R, Beaver JA. Clin Cancer Res. 2020 Aug 15;26(16):4180-4185. doi: 10.1158/1078-0432.CCR-19-3980.
96. NGS Evaluation of Colorectal Cancer Reveals Interferon Gamma Dependent Expression of Immune Checkpoint Genes and Identification of Novel IFNγ Induced Genes. Xu L, Pelosof L, Wang R, McFarland HI, Wu WW, Phue JN, Lee CT, Shen RF, Juhl H, Wu LH, Alterovitz WL, Petricon E, Rosenberg AS. Front Immunol. 2020 Mar 19;11:224. doi: 10.3389/fimmu.2020.00224. eCollection 2020.PMID: 32265897
97. A Bayesian approach in design and analysis of pediatric cancer clinical trials. Ye J, Reaman G, De Claro RA, Sridhara R. Pharm Stat. 2020 Jun 14. doi: 10.1002/pst.2039.

2019

1. Application of the Lung Immune Prognostic Index From Research to Clinical Practice-Reply. Kazandjian D, Gong Y, Blumenthal GM. JAMA Oncol. 2019 Nov 27. doi: 10.1001/jamaoncol.2019.5157.
2. An Analysis of Recent FDA Oncology Scientific Publications. Schneider JA, Miklos AC, Onken J, Gong Y, Calcagno AM, Blumenthal GM, Aragon R, Pazdur R. Oncologist. 2019 Nov 26. pii: theoncologist.2019-0503. doi: 10.1634/ theoncologist.2019-0503.
3. Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer. Agrawal S, Haas NB, Bagheri M, Lane BR, Coleman J, Hammers H, Bratslavsky G, Chauhan C, Kim L, Krishnasamy VP, Marko J, Maher VE, Ibrahim A, Cross F Jr, Liu K, Beaver JA, Pazdur R, Blumenthal GM, Singh H, Plimack ER, Choueiri TK, Uzzo R, Apolo AB. JAMA Oncol. 2019 Nov 21. doi: 10.1001/jamaoncol.2019.4117.
4. An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products. Manning ML, Thompson MD, Saber H, Maher VE, Crich JZ, Leighton JK. Regul Toxicol Pharmacol. 2019 Oct 31;110:104511. doi: 10.1016/j.yrtph.2019.104511.
5. Reply to H. McLeod et al. Weinstock C, Fernandes LL, Theoret M, Tang S, Sridhara R, Beaver JA, Pazdur R. J Clin Oncol. 2019 Nov 1:JCO1902429. doi: 10.1200/JCO.19.02429.
6. Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development. Ahmed MA, Patel C, Drezner N, Helms W, Tan W, Stypinski D. Clin Transl Sci. 2019 Oct 31. doi: 10.1111/cts.12703. Review.
7. Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer. Apolo AB, Milowsky MI, Kim L, Inman BA, Kamat AM, Steinberg G, Bagheri M, Krishnasamy VP, Marko J, Dinney CP, Bangs R, Sweis RF, Maher VE, Ibrahim A, Liu K, Werntz R, Cross F, Beaver JA, Singh H, Pazdur R, Blumenthal GM, Lerner SP, Bajorin DF, Rosenberg JE, Agrawal S. JAMA Oncol. 2019 Oct 31:1-9. doi: 10.1001/jamaoncol.2019.4114.
8. FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer. Wedam S, Fashoyin-Aje L, Bloomquist E, Tang S, Sridhara R, Goldberg KB, Theoret MR, Amiri-Kordestani L, Pazdur R, Beaver JA. Clin Cancer Res. 2019 Oct 24. pii: clincanres.2580.2019. doi: 10.1158/1078-0432.CCR-19-2580.
9. Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors. Mileham KF, Schenkel C, Chuk MK, Buchmeier A, Perez RP, Hurley P, Levit LA, Garrett-Mayer E, Davis C, Bruinooge SS, Vose J. J Oncol Pract. 2019 Oct 24:JOP1900366. doi: 10.1200/ JOP.19.00366.
10. FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease. Przepiorka D, Luo L, Subramaniam S, Qiu J, Gudi R, Cunningham LC, Nie L, Leong R, Ma L, Sheth C, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R. Oncologist. 2019 Oct 22. pii: theoncologist.2019-0627. doi: 10.1634/ theoncologist.2019-0627.
11. Senna Occidentalis Poisoning: An Uncommon Cause of Liver Failure. Ish P, Rathi S, Singh H, Anuradha S. ACG Case Rep J. 2019 Apr 8;6(4):e00035. doi: 10.14309/crj.0000000000000035. eCollection 2019 Apr.
12. Fatal neutropenic enterocolitis associated with docetaxel use: A review of cases reported to the United States Food and Drug Administration Adverse Event Reporting System. Singh P, Nayernama A, Christopher Jones S, Amiri Kordestani L, Fedenko K, Prowell T, Bersoff-Matcha SJ. J Oncol Pharm Pract. 2019 Oct 8:1078155219879494. doi: 10.1177/1078155219879494.
13. US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017. Fiero MH, Roydhouse JK, Vallejo J, King-Kallimanis BL, Kluetz PG, Sridhara R. Lancet Oncol. 2019 Oct;20(10):e582-e589. doi: 10.1016/S1470- 2045(19)30335-3. Epub 2019 Sep 30. Review.
14. Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis. Howie LJ, Singh H, Bloomquist E, Wedam S, Amiri-Kordestani L, Tang S, Sridhara R, Sanchez J, Prowell TM, Kluetz PG, King-Kallimanis BL, Gao JJ, Ibrahim A, Goldberg KB, Theoret M, Pazdur R, Beaver JA. J Clin Oncol. 2019 Sep 27:JCO1802217. doi: 10.1200/JCO.18.02217.
15. Public-private partnerships in transplant drug development. Albrecht R, Papadopoulos EJ, Campbell M, Daniels S, Kluetz PG, Parekh A, Wang Y. Am J Transplant. 2019 Sep 25. doi: 10.1111/ajt.15604.
16. Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer. Parikh RB, Adamson BJS, Khozin S, Galsky MD, Baxi SS, Cohen A, Mamtani R. JAMA. 2019 Sep 24;322(12):1209- 1211. doi: 10.1001/jama.2019.10650.
17. FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm. Jen EY, Gao X, Li L, Zhuang L, Simpson NE, Aryal B, Wang R, Przepiorka D, Shen YL, Leong R, Liu C, Sheth CM, Bowen S, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R. Clin Cancer Res. 2019 Sep 23. doi: 10.1158/1078-0432.CCR- 19-2329.
18. Cytokine Effects on the Entry of Filovirus Envelope Pseudotyped Virus-Like Particles into Primary Human Macrophages. Stantchev TS, Zack-Taylor A, Mattson N, Strebel K, Broder CC, Clouse KA. Viruses. 2019 Sep 23;11(10). pii: E889. doi: 10.3390/v11100889.
19. Machine-Learning and Stochastic Tumor Growth Models for Predicting Outcomes in Patients With Advanced Non-Small-Cell Lung Cancer. Siah KW, Khozin S, Wong CH, Lo AW. JCO Clin Cancer Inform. 2019 Sep;3:1-11. doi: 10.1200/CCI.19.00046.
20. 20. Recent drug approvals for acute myeloid leukemia. Lai C, Doucette K, Norsworthy K. J Hematol Oncol. 2019 Sep 18;12(1):100. doi: 10.1186/s13045-019-0774-x. Review.
21. Exposure to TNF antagonist therapies induces variations of the gut microbiota in an in vivo model using healthy mice. Gabay O, Vicenty J, Zack-Taylor A, Tiffany L, Wunderlin G, Smith D, Reyes-Munoz L, Edwards V, Wu WW, Phue JN, Santana-Quintero L, Lam PV, Clouse KA. Joint Bone Spine. 2019 Sep 9. pii: S1297-319X(19)30119-8. doi: 10.1016/j.jbspin.2019.08.001.
22. Global Variation in Opioid Use in Prostate Cancer Trials. Roydhouse JK, Suzman DL, Menapace LA, Mishra-Kalyani PS, Sridhara R, Blumenthal GM, Beaver JA, Pazdur R, Kluetz PG. JAMA Oncol. 2019 Sep 12:e192971. doi: 10.1001/ jamaoncol.2019.2971.
23. Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop. Weinstock C, Suzman D, Kluetz P, Baxley J, Viviano C, Ibrahim A, Jarow J, Sridhara R, Liu K, Carroll P, Eggener S, Hu JC, Hussain M, King M, Klein E, Kungel T, Makarov D, Pinto PA, Rini B, Roach M, Sandler H, Schlegel PN, Song D, Goldberg K, Pazdur R, Beaver JA. J Urol. 2020 Jan;203(1):115-119. doi: 10.1097/JU.0000000000000532. Epub 2019 Sep 10.
24. Radiologic Considerations and Standardization of Malignant Pleural Mesothelioma Imaging Within Clinical Trials: Consensus Statement from the NCI Thoracic Malignancy Steering Committee - International Association for the Study of Lung Cancer - Mesothelioma Applied Research Foundation Clinical Trials Planning Meeting. Gill RR, Tsao AS, Kindler HL, Richards WG, Armato SG 3rd, Francis RJ, Gomez DR, Dahlberg S, Rimner A, Simone CB 2nd, de Perrot M, Blumenthal G, Adjei AA, Bueno R, Harpole DH Jr, Hesdorffer M, Hirsch FR, Pass HI, Yorke E, Rosenzweig K, Burt B, Fennell DA, Lindwasser W, Malik S, Peikert T, Mansfield AS, Salgia R, Yang H, Rusch VW, Nowak AK. J Thorac Oncol. 2019 Oct;14(10):1718-1731. doi: 10.1016/j.jtho.2019.08.012. Epub 2019 Aug 27.
25. FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults. Li RJ, Jin R, Liu C, Cao X, Manning ML, Di XM, Przepiorka D, Namuswe F, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R. Clin Cancer Res. 2019 Aug 23. doi: 10.1158/1078-0432.CCR-19-1255.
26. Analyzing patient-reported outcome data when completion differs between arms in open-label trials: an application of principal stratification. Roydhouse JK, Gutman R, Bhatnagar V, Kluetz PG, Sridhara R, Mishra- Kalyani PS. Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1386-1394. doi: 10.1002/pds.4875. Epub 2019 Aug 13.
27. Novel reference genes in colorectal cancer identify a distinct subset of high stage tumors and their associated histologically normal colonic tissues. Xu L, Luo H, Wang R, Wu WW, Phue JN, Shen RF, Juhl H, Wu L, Alterovitz WL, Simonyan V, Pelosof L, Rosenberg AS. BMC Med Genet. 2019 Aug 13;20(1):138. doi: 10.1186/s12881-019-0867-y.
28. Characterizing the Feasibility and Performance of Real-World Tumor Progression End Points and Their Association With Overall Survival in a Large Advanced Non-Small-Cell Lung Cancer Data Set. Griffith SD, Miksad RA, Calkins G, You P, Lipitz NG, Bourla AB, Williams E, George DJ, Schrag D, Khozin S, Capra WB, Taylor MD, Abernethy AP. JCO Clin Cancer Inform. 2019 Aug;3:1-13. doi: 10.1200/CCI.19.00013.
29. Myocarditis in the Setting of Cancer Therapeutics: Proposed Case Definitions for Emerging Clinical Syndromes in Cardio-Oncology Bonaca MP, Olenchock BA, Salem JE, Wiviott SD, Ederhy S, Cohen A, Stewart GC, Choueiri TK, Di Carli M, Allenbach Y, Kumbhani DJ, Heinzerling L, Amiri-Kordestani L, Lyon AR, Thavendiranathan P, Padera R, Lichtman A, Liu PP, Johnson DB, Moslehi J. Circulation. 2019 Jul 2;140(2):80-91.
30. Real-world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non-small cell lung cancer. Khozin S, Miksad RA, Adami J, Boyd M, Brown NR, Gossai A, Kaganman I, Kuk D, Rockland JM, Pazdur R, Torres AZ, Zhi J, Abernethy AP. Cancer. 2019 Nov 15;125(22):4019-4032. doi: 10.1002/ cncr.32383. Epub 2019 Aug 5.
31. Artificial intelligence and machine learning in clinical development: a translational perspective. Shah P, Kendall F, Khozin S, Goosen R, Hu J, Laramie J, Ringel M, Schork N. NPJ Digit Med. 2019 Jul 26;2:69. doi: 10.1038/s41746- 019-0148-3. eCollection 2019. Review.
32. FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome. Kasamon YL, Chen H, de Claro RA, Nie L, Ye J, Blumenthal GM, Farrell AT, Pazdur R. Clin Cancer Res. 2019 Jul 31. doi: 10.1158/1078-0432.CCR-19-2030.
33. Using a Benefit Risk Analysis Approach To Capture Regulatory Decision-Making: Renal Cell Carcinoma. Raju GK, Gurumurthi K, Domike R, Weinstock C, Singh H, Kluetz P, Pazdur R, Woodcock J. Clin Pharmacol Ther. 2019 Jul 29. doi: 10.1002/cpt.1589.
34. Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer. Kazandjian D, Gong Y, Keegan P, Pazdur R, Blumenthal GM. JAMA Oncol. 2019 Jul 25. doi: 10.1001/ jamaoncol.2019.1747.
35. An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non-Small-Cell Lung Cancer. Stewart M, Norden AD, Dreyer N, Henk HJ, Abernethy AP, Chrischilles E, Kushi L, Mansfield AS, Khozin S, Sharon E, Arunajadai S, Carnahan R, Christian JB, Miksad RA, Sakoda LC, Torres AZ, Valice E, Allen J. JCO Clin Cancer Inform. 2019 Jul;3:1-15. doi: 10.1200/CCI.18.00155.
36. An FDA oncology analysis of toxicities associated with PBD-containing antibody-drug conjugates. Saber H, Simpson N, Ricks TK, Leighton JK. Regul Toxicol Pharmacol. 2019 Oct;107:104429. doi: 10.1016/j. yrtph.2019.104429. Epub 2019 Jul 17.
37. Cancer and aging activities at the American society of clinical oncology and beyond: Reflections on the legacy of Dr. Arti Hurria. Levit LA, Singh H, Klepin HD. J Geriatr Oncol. 2019 Jul 15. pii: S1879-4068(19)30302-9. doi: 10.1016/j.jgo.2019.07.007.
38. Erratum: Author Correction: Developing and adopting safe and effective digital biomarkers to improve patient outcomes. Coravos A, Khozin S, Mandl KD. NPJ Digit Med. 2019 May 10;2:40. doi: 10.1038/s41746-019-0119-8. eCollection 2019.
39. Assessing cardiac safety in oncology drug development. Seltzer JH, Gintant G, Amiri-Kordestani L, Singer J, Koplowitz LP, Moslehi JJ, Barac A, Yu AF. Am Heart J. 2019 Aug;214:125-133. doi: 10.1016/j.ahj.2019.04.010. Epub 2019 May 4. Review. No abstract available. Erratum in: Am Heart J. 2019 Dec;218:133.
40. A phase II study of the orally administered negative enantiomer of gossypol (AT-101), a BH3 mimetic, in patients with advanced adrenal cortical carcinoma. Xie H, Yin J, Shah MH, Menefee ME, Bible KC, Reidy-Lagunes D, Kane MA, Quinn DI, Gandara DR, Erlichman C, Adjei AA. Invest New Drugs. 2019 Aug;37(4):755-762. doi: 10.1007/ s10637-019-00797-1. Epub 2019 Jun 6.
41. Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities. Barone A, Casey D, McKee AE, Reaman G. Pediatr Blood Cancer. 2019 Aug;66(8):e27809. doi: 10.1002/pbc.27809. Epub 2019 May 30.
42. Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer. Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA. Adv Ther. 2019 Aug;36(8):2122-2136. doi: 10.1007/s12325-019-00970-1. Epub 2019 May 28.
43. Advancing Drug Development in Gynecologic Malignancies. Beaver JA, Coleman RL, Arend RC, Armstrong DK, Bala S, Mills GB, Sood AK, Herzog TJ. Clin Cancer Res. 2019 Aug 15;25(16):4874-4880. doi: 10.1158/1078-0432. CCR-19-0619. Epub 2019 May 24.
44. Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody. Maher VE, Fernandes LL, Weinstock C, Tang S, Agarwal S, Brave M, Ning YM, Singh H, Suzman D, Xu J, Goldberg KB, Sridhara R, Ibrahim A, Theoret M, Beaver JA, Pazdur R. J Clin Oncol. 2019 Oct 20;37(30):2730-2737. doi: 10.1200/JCO.19.00318. Epub 2019 May 22.
45. Identification and quantification of defective virus genomes in high throughput sequencing data using DVG-profiler, a novel post-sequence alignment processing algorithm. Bosma TJ, Karagiannis K, Santana-Quintero L, Ilyushina N, Zagorodnyaya T, Petrovskaya S, Laassri M, Donnelly RP, Rubin S, Simonyan V, Sauder CJ. PLoS One. 2019 May 17;14(5):e0216944. doi: 10.1371/journal.pone.0216944. eCollection 2019.
46. Preparing Fellows for Graduation: Perspectives on Career Guidance. LaCasce A, Graff S, Gao J, Close J, Boulmay B. Am Soc Clin Oncol Educ Book. 2019 Jan;39:609-614. doi: 10.1200/EDBK_242603. Epub 2019 May 17.
47. Patient-Friendly Language to Facilitate Treatment Choice for Patients with Cancer. Kim J, Gao J, Amiri-Kordestani L, Beaver JA, Kluetz P. Oncologist. 2019 Aug;24(8):1011-1012. doi: 10.1634/theoncologist.2018-0761. Epub 2019 May 16. No abstract available.
48. FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia. Norsworthy KJ, By K, Subramaniam S, Zhuang L, Del Valle PL, Przepiorka D, Shen YL, Sheth CM, Liu C, Leong R, Goldberg KB, Farrell AT, Pazdur R. Clin Cancer Res. 2019 Oct 15;25(20):6021-6025. doi: 10.1158/1078-0432.CCR-19-0365. Epub 2019 May 7.
49. Codon and Codon-Pair Usage Tables (CoCoPUTs): Facilitating Genetic Variation Analyses and Recombinant Gene Design. Alexaki A, Kames J, Holcomb DD, Athey J, Santana-Quintero LV, Lam PVN, Hamasaki-Katagiri N, Osipova E, Simonyan V, Bar H, Komar AA, Kimchi-Sarfaty C. J Mol Biol. 2019 Jun 14;431(13):2434-2441. doi: 10.1016/j. jmb.2019.04.021. Epub 2019 Apr 26.
50. U.S. Food and Drug Administration Benefit-Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission. Pulte ED, Wroblewski T, Bloomquist E, Tang S, Farrell A, Deisseroth A, McKee AE, Pazdur R. Oncologist. 2019 May;24(5):e188-e195. doi: 10.1634/theoncologist.2018-0759. Epub 2019 Apr 24.
51. Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations. Khozin S, Coravos A. Clin Pharmacol Ther. 2019 Jul;106(1):25-27. doi: 10.1002/cpt.1441. Epub 2019 Apr 23. No abstract available.
52. Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma. Raju GK, Gurumurthi K, Domike R, Theoret MR, Pazdur R, Woodcock J. Clin Pharmacol Ther. 2019 Jul;106(1):123-135. doi: 10.1002/ cpt.1461. Epub 2019 May 21.
53. Current Landscape of Immunotherapy in Breast Cancer: A Review. Adams S, Gatti-Mays ME, Kalinsky K, Korde LA, Sharon E, Amiri-Kordestani L, Bear H, McArthur HL, Frank E, Perlmutter J, Page DB, Vincent B, Hayes JF, Gulley JL, Litton JK, Hortobagyi GN, Chia S, Krop I, White J, Sparano J, Disis ML, Mittendorf EA. JAMA Oncol. 2019 Apr 11. doi: 10.1001/jamaoncol.2018.7147.
54. Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model- Informed Drug Development in Oncology. Bruno R, Jin JY, Maxfield K, Milligan L, Liu C, Wang Y, McKee AE, Zineh I. Clin Pharmacol Ther. 2019 Jul;106(1):81-83. doi: 10.1002/cpt.1421. Epub 2019 Apr 5. No abstract available.
55. FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma. Richardson NC, Kasamon YL, Chen H, de Claro RA, Ye J, Blumenthal GM, Farrell AT, Pazdur R. Oncologist. 2019 May;24(5):e180-e187. doi: 10.1634/theoncologist.2019-0098. Epub 2019 Mar 26.
56. Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions. King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, Kluetz PG. Clin Trials. 2019 Jun;16(3):322-326. doi: 10.1177/1740774519836991. Epub 2019 Mar 18.
57. Developing and adopting safe and effective digital biomarkers to improve patient outcomes. Coravos A, Khozin S, Mandl KD. NPJ Digit Med. 2019;2(1). pii: 14. doi: 10.1038/s41746-019-0090-4. Epub 2019 Mar 11. Erratum in: NPJ Digit Med. 2019 May 10;2:40.
58. US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials. Regnante JM, Richie NA, Fashoyin-Aje L, Vichnin M, Ford M, Roy UB, Turner K, Hall LL, Gonzalez E, Esnaola N, Clark LT, Adams HC 3rd, Alese OB, Gogineni K, McNeill L, Petereit D, Sargeant I, Dang J, Obasaju C, Highsmith Q, Lee SC, Hoover SC, Williams EL, Chen MS Jr. J Oncol Pract. 2019 Apr;15(4):e289-e299. doi: 10.1200/ JOP.18.00638. Epub 2019 Mar 4.
59. Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Initial Report of Findings, 2012-2018. McCarthy CM, Loyo-Berríos N, Qureshi AA, Mullen E, Gordillo G, Pusic AL, Ashar BS, Sommers K, Clemens MW. Plast Reconstr Surg. 2019 Mar;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):65S-73S. doi: 10.1097/PRS.0000000000005571.
60. Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer. Blumenthal GM, Gong Y, Kehl K, Mishra-Kalyani P, Goldberg KB, Khozin S, Kluetz PG, Oxnard GR, Pazdur R. Ann Oncol. 2019 May 1;30(5):830-838. doi: 10.1093/annonc/mdz060.
61. FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors. Marcus L, Lemery SJ, Keegan P, Pazdur R. Clin Cancer Res. 2019 Jul 1;25(13):3753-3758. doi: 10.1158/1078- 0432.CCR-18-4070. Epub 2019 Feb 20.
62. ACCELERATE and European Medicine Agency Paediatric Strategy Forum for medicinal product development for mature B-cell malignancies in children. Pearson ADJ, Scobie N, Norga K, Ligas F, Chiodin D, Burke A, Minard-Colin V, Adamson P, Marshall LV, Balakumaran A, Benettaib B, Bhargava P, Bollard CM, Bolotin E, Bomken S, Buechner J, Burkhardt B, Caron H, Copland C, Demolis P, Egorov A, Farhan M, Zugmaier G, Gross T, Horton-Taylor D, Klapper W, Lesa G, Marcus R, Miles RR, Nottage K, Pacaud L, Ricafort R, Schrappe M, Sterba J, Vezan R, Weiner S, Kim SY, Reaman G, Vassal G. Eur J Cancer. 2019 Mar;110:74-85. doi: 10.1016/j.ejca.2019.01.013. Epub 2019 Feb 14.
63. Residual Disease after Neoadjuvant Therapy - Developing Drugs for High-Risk Early Breast Cancer. Prowell TM, Beaver JA, Pazdur R. N Engl J Med. 2019 Feb 14;380(7):612-615. doi: 10.1056/NEJMp1900079. No abstract available.
64. Model-Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First-Line Anaplastic Lymphoma Kinase + Non-Small Cell Lung Cancer. Morcos PN, Liu J, Blumenthal GM, Zhao H. Clin Pharmacol Ther. 2019 Apr;105(4):826-828. doi: 10.1002/cpt.1340. Epub 2019 Feb 5.
65. Challenges with Novel Clinical Trial Designs: Master Protocols. Cecchini M, Rubin EH, Blumenthal GM, Ayalew K, Burris HA, Russell-Einhorn M, Dillon H, Lyerly HK, Reaman GH, Boerner S, LoRusso PM. Clin Cancer Res. 2019 Apr 1;25(7):2049-2057. doi: 10.1158/1078-0432.CCR-18-3544. Epub 2019 Jan 29.
66. FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation. Norsworthy KJ, Luo L, Hsu V, Gudi R, Dorff SE, Przepiorka D, Deisseroth A, Shen YL, Sheth CM, Charlab R, Williams GM, Goldberg KB, Farrell AT, Pazdur R. Clin Cancer Res. 2019 Jun 1;25(11):3205- 3209. doi: 10.1158/1078-0432.CCR-18-3749. Epub 2019 Jan 28.
67. Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review. Blumenthal GM, Pazdur R. Nat Rev Clin Oncol. 2019 Mar;16(3):139-141. doi: 10.1038/s41571-019-0170-z.
68. Investigating Potential Bias in Patient-Reported Outcomes in Open-label Cancer Trials. Roydhouse JK, Fiero MH, Kluetz PG. JAMA Oncol. 2019 Apr 1;5(4):457-458. doi: 10.1001/jamaoncol.2018.6205.
69. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Gao JJ, Cheng J, Bloomquist E, Sanchez J, Wedam SB, Singh H, Amiri-Kordestani L, Ibrahim A, Sridhara R, Goldberg KB, Theoret MR, Kluetz PG, Blumenthal GM, Pazdur R, Beaver JA, Prowell TM. Lancet Oncol. 2019 Dec 16. pii: S1470-2045(19)30804-6. doi: 10.1016/ S1470-2045(19)30804-6. [Epub ahead of print]
70. Idelalisib for Treatment of Relapsed Follicular Lymphoma and Chronic Lymphocytic Leukemia: A Comparison of Treatment Outcomes in Clinical Trial Participants vs Medicare Beneficiaries. Bird ST, Tian F, Flowers N, Przepiorka D, Wang R, Jung TH, Kessler Z, Woods C, Kim B, Miller BW, Wernecke M, Kim C, McKean S, Gelperin K, MaCurdy TE, Kelman JA, Graham DJ. JAMA Oncol. 2019 Dec 19. doi: 10.1001/jamaoncol.2019.3994. [Epub ahead of print]
71. Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs. Kim J, Nair A, Keegan P, Beaver JA, Kluetz PG, Pazdur R, Chuk M, Blumenthal GM. Oncologist. 2019 Dec 17. pii: theoncologist.2019-0653. doi: 10.1634/theoncologist.2019-0653. [Epub ahead of print].
72. End points for sickle cell disease clinical trials: patient-reported outcomes, pain, and the brain. Farrell AT, Panepinto J, Carroll CP, Darbari DS, Desai AA, King AA, Adams RJ, Barber TD, Brandow AM, DeBaun MR, Donahue MJ, Gupta K, Hankins JS, Kameka M, Kirkham FJ, Luksenburg H, Miller S, Oneal PA, Rees DC, Setse R, Sheehan VA, Strouse J, Stucky CL, Werner EM, Wood JC, Zempsky WT. Blood Adv. 2019 Dec 10;3(23):3982-4001. doi: 10.1182/bloodadvances.2019000882.
73. End points for sickle cell disease clinical trials: renal and cardiopulmonary, cure, and low-resource settings. Farrell AT, Panepinto J, Desai AA, Kassim AA, Lebensburger J, Walters MC, Bauer DE, Blaylark RM, DiMichele DM, Gladwin MT, Green NS, Hassell K, Kato GJ, Klings ES, Kohn DB, Krishnamurti L, Little J, Makani J, Malik P, McGann PT, Minniti C, Morris CR, Odame I, Oneal PA, Setse R, Sharma P, Shenoy S. Blood Adv. 2019 Dec 10;3(23):4002- 4020. doi: 10.1182/bloodadvances.2019000883.

2018

1. Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval. Khozin S, Carson KR, Zhi J, Tucker M, Lee SE, Light DE, Curtis MD, Bralic M, Kaganman I, Gossai A, Hofmeister P, Torres AZ, Miksad RA, Blumenthal GM, Pazdur R, Abernethy AP. Oncologist. 2018 Dec 27. pii: theoncologist.2018-0307. doi: 10.1634/theoncologist.2018-0307. [Epub ahead of print]
2. Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology. Hobbs BP, Barata PC, Kanjanapan Y, Paller CJ, Perlmutter J, Pond GR, Prowell TM, Rubin EH, Seymour LK, Wages NA, Yap TA, Feltquate D, Garrett-Mayer E, Grossman W, Hong DS, Ivy SP, Siu LL, Reeves SA, Rosner GL. J Natl Cancer Inst. 2018 Dec 17. doi: 10.1093/jnci/djy196. [Epub ahead of print]
3. Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007-2017. Roydhouse JK, King-Kallimanis BL, Howie LJ, Singh H, Kluetz PG. J Natl Cancer Inst. 2018 Dec 17. doi: 10.1093/jnci/djy181. [Epub ahead of print]
4. FDA Approval Summary: Pertuzumab for adjuvant treatment of HER2-positive early breast cancer. Howie LJ, Scher NS, Amiri-Kordestani L, Zhang L, King-Kallimanis BL, Choudhry Y, Schroeder J, Goldberg KB, Kluetz PG, Ibrahim A, Sridhara R, Blumenthal GM, Pazdur R, Beaver JA. Clin Cancer Res. 2018 Dec 14. pii: clincanres.3003.2018. doi: 10.1158/1078-0432.CCR-18-3003. [Epub ahead of print]
5. FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy. Suzman DL, Agrawal S, Ning YM, Maher VE, Fernandes LL, Karuri S, Tang S, Sridhara R, Schroeder J, Goldberg KB, Ibrahim A, McKee AE, Pazdur R, Beaver JA. Oncologist. 2018 Dec 12. pii: theoncologist.2018-0084. doi: 10.1634/theoncologist.2018-0084. [Epub ahead of print]
6. FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia. Krauss AC, Gao X, Li L, Manning ML, Patel P, Fu W, Janoria KG, Gieser G, Bateman DA, Przepiorka D, Shen YL, Shord SS, Sheth CM, Banerjee A, Liu J, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R. Clin Cancer Res. 2018 Dec 12. pii: clincanres.2990.2018. doi: 10.1158/1078-0432.CCR-18-2990. [Epub ahead of print]
7. In-Depth Comparative Analysis of Illumina® MiSeq Run Metrics: Development of a Wet-lab Quality Assessment Tool. Kastanis GJ, Santana-Quintero LV, Sanchez-Leon M, Lomonaco S, Brown EW, Allard MW. Mol Ecol Resour. 2018 Dec 2. doi: 10.1111/1755-0998.12973. [Epub ahead of print]
8. Wound healing complications with lenvatinib identified in a pharmacovigilance database. Cheng C, Nayernama A, Christopher Jones S, Casey D, Waldron PE. J Oncol Pharm Pract. 2018 Nov 30:1078155218817109. doi: 10.1177/1078155218817109. [Epub ahead of print]
9. Clinical Development of Novel Drug-Radiotherapy Combinations. Ahmad SS, Crittenden MR, Tran PT, Kluetz PG, Blumenthal GM, Bulbeck H, Baird RD, Williams KJ, Illidge T, Hahn S, Lawrence TS, Spears PA, Walker AJ, Sharma RA. Clin Cancer Res. 2018 Nov 29. pii: clincanres.2466.2018. doi: 10.1158/1078-0432.CCR-18-2466. [Epub ahead of print]
10. Assessing function of electronic health records for real-world data generation. Guinn D, Wilhelm EE, Lieberman G, Khozin S. BMJ Evid Based Med. 2018 Nov 26. pii: bmjebm-2018-111111. doi: 10.1136/bmjebm-2018-111111. [Epub ahead of print]
11. FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma. Bouchkouj N, Kasamon YL, de Claro RA, George B, Lin X, Lee S, Blumenthal GM, Bryan W, McKee AE, Pazdur R. Clin Cancer Res. 2018 Nov 9. pii: clincanres.2743.2018. doi: 10.1158/1078-0432.CCR-18-2743. [Epub ahead of print]
12. Summary of the Second Annual BMT CTN Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling. Holstein SA, Ye JC, Howard A, Bhutani M, Gormley N, Hahn T, Hillengass J, Krishnan A, Landgren CO, Munshi NC, Oliva S, Owen RG, Pasquini MC, Puig N, Weinhold N, Weisel K, McCarthy PL. Biol Blood Marrow Transplant. 2018 Nov 5. pii: S1083-8791(18)30694-3. doi: 10.1016/j.bbmt.2018.11.001. [Epub ahead of print]
13. Tumour-targeting bacteria engineered to fight cancer. Zhou S, Gravekamp C, Bermudes D, Liu K. Nat Rev Cancer. 2018 Dec;18(12):727-743. doi: 10.1038/s41568-018-0070-z.
14. Immunotherapy Combinations in Multiple Myeloma - Known Unknowns. Gormley NJ, Pazdur R. N Engl J Med. 2018 Nov 8;379(19):1791-1795. doi: 10.1056/NEJMp1803602.
15. FDA analyses of survival in older adults with metastatic non-small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies. Marur S, Singh H, Mishra-Kalyani P, Larkins E, Keegan P, Sridhara R, Blumenthal GM, Pazdur R. Semin Oncol. 2018 Aug;45(4):220-225. doi: 10.1053/j.seminoncol.2018.08.007. Epub 2018 Oct 31.
16. Target-Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities. Schotland P, Racz R, Jackson D, Levin R, Strauss DG, Burkhart K. CPT Pharmacometrics Syst Pharmacol. 2018 Dec;7(12):809-817. doi: 10.1002/psp4.12356. Epub 2018 Oct 24.
17. Learning from Patients: Reflections on Use of Patient-Reported Outcomes in Lung Cancer Trials. Basu Roy U, King-Kallimanis BL, Kluetz PG, Selig W, Ferris A. J Thorac Oncol. 2018 Dec;13(12):1815-1817. doi: 10.1016/j.jtho.2018.09.003. Epub 2018 Oct 15. No abstract available.
18. Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop. Levit LA, Singh H, Klepin HD, Hurria A. J Natl Cancer Inst. 2018 Nov 1;110(11):1163-1170. doi: 10.1093/jnci/djy169.
19. FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia. O'Leary MC, Lu X, Huang Y, Lin X, Mahmood I, Przepiorka D, Gavin D, Lee S, Liu K, George B, Bryan W, Theoret MR, Pazdur R. Clin Cancer Res. 2018 Oct 11. doi: 10.1158/1078-0432.CCR-18-2035. [Epub ahead of print]
20. Phase I/II Trial of Vandetanib and Bortezomib in Adults with Locally Advanced or Metastatic Medullary Thyroid Cancer. Del Rivero J, Edgerly M, Ward J, Madan RA, Balasubramaniam S, Fojo T, Gramza AW. Oncologist. 2019 Jan;24(1):16-e14. doi: 10.1634/theoncologist.2018-0452. Epub 2018 Oct 8.
21. Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer. Blumenthal GM, Bunn PA Jr, Chaft JE, McCoach CE, Perez EA, Scagliotti GV, Carbone DP, Aerts HJWL, Aisner DL, Bergh J, Berry DA, Jarkowski A, Botwood N, Cross DAE, Diehn M, Drezner NL, Doebele RC, Blakely CM, Eberhardt WEE, Felip E, Gianni L, Keller SP, Leavey PJ, Malik S, Pignatti F, Prowell TM, Redman MW, Rizvi NA, Rosell R, Rusch V, de Ruysscher D, Schwartz LH, Sridhara R, Stahel RA, Swisher S, Taube JM, Travis WD, Keegan P, Wiens JR, Wistuba II, Wynes MW, Hirsch FR, Kris MG. J Thorac Oncol. 2018 Dec;13(12):1818-1831. doi: 10.1016/j.jtho.2018.09.017. Epub 2018 Sep 27.
22. Current and Future Management of Malignant Mesothelioma: A Consensus Report from the National Cancer Institute Thoracic Malignancy Steering Committee, International Association for the Study of Lung Cancer, and Mesothelioma Applied Research Foundation. Tsao AS, Lindwasser OW, Adjei AA, Adusumilli PS, Beyers ML, Blumenthal GM, Bueno R, Burt BM, Carbone M, Dahlberg SE, de Perrot M, Fennell DA, Friedberg J, Gill RR, Gomez DR, Harpole DH Jr, Hassan R, Hesdorffer M, Hirsch FR, Hmeljak J, Kindler HL, Korn EL, Liu G, Mansfield AS, Nowak AK, Pass HI, Peikert T, Rimner A, Robinson BWS, Rosenzweig KE, Rusch VW, Salgia R, Sepesi B, Simone CB 2nd, Sridhara R, Szlosarek P, Taioli E, Tsao MS, Yang H, Zauderer MG, Malik SM. J Thorac Oncol. 2018 Nov;13(11):1655-1667. doi: 10.1016/j.jtho.2018.08.2036. Epub 2018 Sep 25.
23. FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease. Jen EY, Xu Q, Schetter A, Przepiorka D, Shen YL, Roscoe D, Sridhara R, Deisseroth A, Philip R, Farrell AT, Pazdur R. Clin Cancer Res. 2018 Sep 25. doi: 10.1158/1078-0432.CCR-18-2337. [Epub ahead of print]
24. No Decision Is Final: Career Planning and Career Transitions. Boulmay B, Prowell T, Blaya M, Pietanza MC. Am Soc Clin Oncol Educ Book. 2018 May 23;(38):881-886. doi: 10.1200/EDBK_200983.
25. Progress Through Collaboration: An ASCO and U.S. Food and Drug Administration Workshop to Improve the Evidence Base for Treating Older Adults With Cancer. Singh H, Hurria A, Klepin HD. Am Soc Clin Oncol Educ Book. 2018 May 23;(38):392-399. doi: 10.1200/EDBK_201133.
26. Complexity of Delivering Precision Medicine: Opportunities and Challenges. Davis AA, McKee AE, Kibbe WA, Villaflor VM. Am Soc Clin Oncol Educ Book. 2018 May 23;(38):998-1007. doi: 10.1200/EDBK_200279.
27. Assessing the Risks of Breast Implants and FDA's Vision for the National Breast Implant Registry. Ashar BS. Ann Surg. 2019 Jan;269(1):37-38. doi: 10.1097/SLA.0000000000003052.
28. National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer. Seidman AD, Bordeleau L, Fehrenbacher L, Barlow WE, Perlmutter J, Rubinstein L, Wedam SB, Hershman DL, Hayes JF, Butler LP, Smith ML, Regan MM, Beaver JA, Amiri-Kordestani L, Rastogi P, Zujewski JA, Korde LA. J Clin Oncol. 2018 Sep 13:JCO1800242. doi: 10.1200/JCO.18.00242. [Epub ahead of print]
29. Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials. Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro JZ, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Sridhara R, Taphoorn MJB, Velikova G, Coens C. Clin Trials. 2018 Dec;15(6):624-630. doi: 10.1177/1740774518795637. Epub 2018 Aug 24.
30. FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1. Fashoyin-Aje L, Donoghue M, Chen H, He K, Veeraraghavan J, Goldberg KB, Keegan P, McKee AE, Pazdur R. Oncologist. 2019 Jan;24(1):103-109. doi: 10.1634/theoncologist.2018-0221. Epub 2018 Aug 17.
31. FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAFV600 Mutation. Oneal PA, Kwitkowski V, Luo L, Shen YL, Subramaniam S, Shord S, Goldberg KB, McKee AE, Kaminskas E, Farrell A, Pazdur R. Oncologist. 2018 Aug 17. pii: theoncologist.2018-0295. doi: 10.1634/theoncologist.2018-0295. [Epub ahead of print]
32. FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis. Kasamon YL, Ko CW, Subramaniam S, Ma L, Yang Y, Nie L, Shord S, Przepiorka D, Farrell AT, McKee AE, Pazdur R. Oncologist. 2018 Aug 16. pii: theoncologist.2018-0222. doi: 10.1634/theoncologist.2018-0222. [Epub ahead of print]
33. Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016. Zhou J, Vallejo J, Kluetz P, Pazdur R, Kim T, Keegan P, Farrell A, Beaver JA, Sridhara R. J Natl Cancer Inst. 2018 Aug 4. doi: 10.1093/jnci/djy130. [Epub ahead of print]
34. White paper on microbial anti-cancer therapy and prevention. Forbes NS, Coffin RS, Deng L, Evgin L, Fiering S, Giacalone M, Gravekamp C, Gulley JL, Gunn H, Hoffman RM, Kaur B, Liu K, Lyerly HK, Marciscano AE, Moradian E, Ruppel S, Saltzman DA, Tattersall PJ, Thorne S, Vile RG, Zhang HH, Zhou S, McFadden G. J Immunother Cancer. 2018 Aug 6;6(1):78. doi: 10.1186/s40425-018-0381-3.
35. Upper gastrointestinal acute graft-versus-host disease adds minimal prognostic value in isolation or with other graft-versus-host disease symptoms as currently diagnosed and treated. Nikiforow S, Wang T, Hemmer M, Spellman S, Akpek G, Antin JH, Choi SW, Inamoto Y, Khoury HJ, MacMillan M, Marks DI, Meehan K, Nakasone H, Nishihori T, Olsson R, Paczesny S, Przepiorka D, Reddy V, Reshef R, Schoemans H, Waller N, Weisdorf D, Wirk B, Horowitz M, Alousi A, Couriel D, Pidala J, Arora M, Cutler C; GV12-02 Writing Committee on behalf of the CIBMTR® Graft-versus-Host Disease Working Committee. Haematologica. 2018 Oct;103(10):1708-1719. doi: 10.3324/haematol.2017.182550. Epub 2018 Aug 3.
36. FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia. Pulte ED, Vallejo J, Przepiorka D, Nie L, Farrell AT, Goldberg KB, McKee AE, Pazdur R. Oncologist. 2018 Nov;23(11):1366-1371. doi: 10.1634/theoncologist.2018-0179. Epub 2018 Jul 17.
37. Determination of Similarity Margin in Comparative Clinical Studies to Support the Development of Biosimilar Products of Neupogen® (Filgrastim, Granulocyte Colony-Stimulating Factor [G-CSF]). Nie L, Przepiorka D, Deisseroth A, Sridhara R, Gwise TE. BioDrugs. 2018 Jul 13. doi: 10.1007/s40259-018-0288-z. [Epub ahead of print]
38. Clinical trial design for cutaneous neurofibromas. Cannon A, Jarnagin K, Korf B, Widemann BC, Casey D, Ko HS, Blakeley JO, Verma SK, Pichard DC. Neurology. 2018 Jul 10;91(2 Supplement 1):S31-S37. doi: 10.1212/WNL.0000000000005790.
39. Ipilimumab plus nivolumab and DNA-repair defects in AR-V7-expressing metastatic prostate cancer. Boudadi K, Suzman DL, Anagnostou V, Fu W, Luber B, Wang H, Niknafs N, White JR, Silberstein JL, Sullivan R, Dowling D, Harb R, Nirschl TR, Veeneman BA, Tomlins SA, Wang Y, Jendrisak A, Graf RP, Dittamore R, Carducci MA, Eisenberger MA, Haffner MC, Meeker AK, Eshleman JR, Luo J, Velculescu VE, Drake CG, Antonarakis ES. Oncotarget. 2018 Jun 19;9(47):28561-28571. doi: 10.18632/oncotarget.25564. eCollection 2018 Jun 19.
40. A population pharmacokinetic/toxicity model for the reduction of platelets during a 48-h continuous intravenous infusion of the histone deacetylase inhibitor belinostat. Peer CJ, Hall OM, Sissung TM, Piekarz R, Balasubramaniam S, Bates SE, Figg WD. Cancer Chemother Pharmacol. 2018 Sep;82(3):565-570. doi: 10.1007/s00280-018-3631-7. Epub 2018 Jun 27.
41. Metastasis-free Survival - A New End Point in Prostate Cancer Trials. Beaver JA, Kluetz PG, Pazdur R. N Engl J Med. 2018 Jun 28;378(26):2458-2460. doi: 10.1056/NEJMp1805966.
42. Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop. Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ. Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7.
43. Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies. Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Krauss A, Kwong YL, Little RF, Mahon FX, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Rule S, Sloan J, Sonneveld P, Thompson CA, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Wintrich S, Seymour JF, Habermann TM. Lancet Haematol. 2018 Nov;5(11):e563-e598. doi: 10.1016/S2352-3026(18)30051-6. Epub 2018 Jun 18.
44. Prevention of cisplatin-induced hearing loss in children: Informing the design of future clinical trials. Minasian LM, Frazier AL, Sung L, O'Mara A, Kelaghan J, Chang KW, Krailo M, Pollock BH, Reaman G, Freyer DR. Cancer Med. 2018 May 30. doi: 10.1002/cam4.1563. [Epub ahead of print]
45. Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action. Neilan TG, Rothenberg ML, Amiri-Kordestani L, Sullivan RJ, Steingart RM, Gregory W, Hariharan S, Hammad TA, Lindenfeld J, Murphy MJ, Moslehi JJ; Checkpoint Inhibitor Safety Working Group. Oncologist. 2018 Aug;23(8):874-878. doi: 10.1634/theoncologist.2018-0157. Epub 2018 May 25.
46. Treatment of Nonmetastatic Unilateral Retinoblastoma in Children. Pérez V, Sampor C, Rey G, Parareda-Salles A, Kopp K, Dabezies AP, Dufort G, Zelter M, López JP, Urbieta M, Alcalde-Ruiz E, Catala-Mora J, Suñol M, Ossandon D, Fandiño AC, Croxatto JO, de Dávila MTG, Reaman G, Ravindranath Y, Chantada GL. JAMA Ophthalmol. 2018 Jul 1;136(7):747-752. doi: 10.1001/jamaophthalmol.2018.1501.
47. Making Lung Cancer Clinical Trials More Inclusive: Recommendations for Expanding Eligibility Criteria. Bonomi P, Blumenthal G, Ferris AS, Stewart DJ, Selig WKD, Krug LM, Allen J, Ison G, Langer CJ, Melemed A, Odogwu L, Basu Roy U, Sandler A. J Thorac Oncol. 2018 Jun;13(6):748-751. doi: 10.1016/j.jtho.2018.02.013.
48. Ibrutinib-associated ventricular arrhythmia in the FDA Adverse Event Reporting System. Cheng C, Woronow D, Nayernama A, Wroblewski T, Jones SC. Leuk Lymphoma. 2018 Dec;59(12):3016-3017. doi: 10.1080/10428194.2018.1457149. Epub 2018 May 24.
49. Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols. Khan T, Stewart M, Blackman S, Rousseau R, Donoghue M, Cohen K, Seibel N, Fleury M, Benettaib B, Malik R, Vassal G, Reaman G. Ther Innov Regul Sci. 2018 Jan 1:2168479018774533. doi: 10.1177/2168479018774533. [Epub ahead of print]
50. FDA's Approval of the First Biosimilar to Bevacizumab. Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY, Yuan W, Rodriguez L, Gwise T, Rowzee A, Lim S, Keegan P, McKee AE, Pazdur R. Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9.
51. Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study. Agarwala V, Khozin S, Singal G, O'Connell C, Kuk D, Li G, Gossai A, Miller V, Abernethy AP. Health Aff (Millwood). 2018 May;37(5):765-772. doi: 10.1377/hlthaff.2017.1579.
52. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. Kluetz PG, O'Connor DJ, Soltys K. Lancet Oncol. 2018 May;19(5):e267-e274. doi: 10.1016/S1470-2045(18)30097-4.
53. Anti-PD-1 antibody treatment for melanoma - Authors' reply. Beaver JA, Keegan P, Lemery S, Pazdur R, Theoret MR. Lancet Oncol. 2018 May;19(5):e220. doi: 10.1016/S1470-2045(18)30251-1.
54. FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy. Ison G, Howie LJ, Amiri-Kordestani L, Zhang L, Tang S, Sridhara R, Pierre V, Charlab R, Ramamoorthy A, Song P, Li F, Yu J, Manheng W, Palmby TR, Ghosh S, Horne HN, Lee EY, Philip R, Dave K, Chen XH, Kelly SL, Janoria KG, Banerjee A, Eradiri O, Dinin J, Goldberg KB, Pierce WF, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R. Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12.
55. FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia. Norsworthy KJ, Ko CW, Lee JE, Liu J, John CS, Przepiorka D, Farrell AT, Pazdur R. Oncologist. 2018 Sep;23(9):1103-1108. doi: 10.1634/theoncologist.2017-0604. Epub 2018 Apr 12.
56. Breakthrough-Therapy Designation - An FDA Perspective. Corrigan-Curay J, McKee AE, Stein P. N Engl J Med. 2018 Apr 12;378(15):1457-1458. doi: 10.1056/NEJMc1801222.
57. INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology. Khozin S, Pazdur R, Shah A. Nat Rev Drug Discov. 2018 Aug;17(8):529-530. doi: 10.1038/nrd.2018.34. Epub 2018 Apr 6.
58. FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome. Le RQ, Li L, Yuan W, Shord SS, Nie L, Habtemariam BA, Przepiorka D, Farrell AT, Pazdur R. Oncologist. 2018 Aug;23(8):943-947. doi: 10.1634/theoncologist.2018-0028. Epub 2018 Apr 5.
59. Hepatotoxicity of immune checkpoint inhibitors: An evolving picture of risk associated with a vital class of immunotherapy agents. Suzman DL, Pelosof L, Rosenberg A, Avigan MI. Liver Int. 2018 Jun;38(6):976-987. doi: 10.1111/liv.13746. Epub 2018 Apr 24.
60. U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer. Singh H, Walker AJ, Amiri-Kordestani L, Cheng J, Tang S, Balcazar P, Barnett-Ringgold K, Palmby TR, Cao X, Zheng N, Liu Q, Yu J, Pierce WF, Daniels SR, Sridhara R, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R. Clin Cancer Res. 2018 Aug 1;24(15):3486-3491. doi: 10.1158/1078-0432.CCR-17-3628. Epub 2018 Mar 9.
61. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
62. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review. Beaver JA, Howie LJ, Pelosof L, Kim T, Liu J, Goldberg KB, Sridhara R, Blumenthal GM, Farrell AT, Keegan P, Pazdur R, Kluetz PG. JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618.
63. Leveraging the Success of HIV Drug Development Paradigms for Cancer. Blumenthal GM, Birnkrant D, Pazdur R. Clin Cancer Res. 2018 Jun 1;24(11):2491-2492. doi: 10.1158/1078-0432.CCR-18-0544. Epub 2018 Feb 28.
64. FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia. Jen EY, Ko CW, Lee JE, Del Valle PL, Aydanian A, Jewell C, Norsworthy KJ, Przepiorka D, Nie L, Liu J, Sheth CM, Shapiro M, Farrell AT, Pazdur R. Clin Cancer Res. 2018 Jul 15;24(14):3242-3246. doi: 10.1158/1078-0432.CCR-17-3179. Epub 2018 Feb 23.
65. Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease. Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M. Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23.
66. FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma. Pulte ED, Dmytrijuk A, Nie L, Goldberg KB, McKee AE, Farrell AT, Pazdur R. Oncologist. 2018 Jun;23(6):734-739. doi: 10.1634/theoncologist.2017-0440. Epub 2018 Feb 7.
67. FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non-Small Cell Lung Cancers Harboring BRAF V600E Mutations. Odogwu L, Mathieu L, Blumenthal G, Larkins E, Goldberg KB, Griffin N, Bijwaard K, Lee EY, Philip R, Jiang X, Rodriguez L, McKee AE, Keegan P, Pazdur R. Oncologist. 2018 Jun;23(6):740-745. doi: 10.1634/theoncologist.2017-0642. Epub 2018 Feb 7.
68. FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. Shah A, Bloomquist E, Tang S, Fu W, Bi Y, Liu Q, Yu J, Zhao P, Palmby TR, Goldberg KB, Chang CJG, Patel P, Alebachew E, Tilley A, Pierce WF, Ibrahim A, Blumenthal GM, Sridhara R, Beaver JA, Pazdur R. Clin Cancer Res. 2018 Jul 1;24(13):2999-3004. doi: 10.1158/1078-0432.CCR-17-2369. Epub 2018 Feb 7.
69. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT; the SPIRIT-PRO Group, Hunn A, Bottomley A, Regnault A, Chan AW, Ells C, O'Connor D, Revicki D, Patrick D, Altman D, Basch E, Velikova G, Price G, Draper H, Blazeby J, Scott J, Coast J, Norquist J, Brown J, Haywood K, Johnson LL, Campbell L, Frank L, von Hildebrand M, Brundage M, Palmer M, Kluetz P, Stephens R, Golub RM, Mitchell S, Groves T. JAMA. 2018 Feb 6;319(5):483-494. doi: 10.1001/jama.2017.21903.
70. Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients. Li L, Ma L, Schrieber SJ, Rahman NA, Deisseroth A, Farrell AT, Wang Y, Sinha V, Marathe A. Clin Pharmacol Ther. 2018 Oct;104(4):742-748. doi: 10.1002/cpt.991. Epub 2018 Feb 2.
71. Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib. Pelosof L, Lemery S, Casak S, Jiang X, Rodriguez L, Pierre V, Bi Y, Liu J, Zirkelbach JF, Patel A, Goldberg KB, McKee AE, Keegan P, Pazdur R. Oncologist. 2018 Apr;23(4):496-500. doi: 10.1634/theoncologist.2017-0422. Epub 2018 Jan 31.
72. Approvals in 2017: gene therapies and site-agnostic indications. Blumenthal GM, Pazdur R. Nat Rev Clin Oncol. 2018 Mar;15(3):127-128. doi: 10.1038/nrclinonc.2018.11. Epub 2018 Jan 31.
73. Survival of ethnic and racial minority patients with multiple myeloma treated with newer medications. Pulte ED, Nie L, Gormley N, Goldberg KB, McKee A, Farrell A, Pazdur R. Blood Adv. 2018 Jan 23;2(2):116-119. doi: 10.1182/bloodadvances.2017010512.
74. The US Food and Drug Administration's Approach for Safe Innovation of Medical Devices in Dermatology. Chang CJ, Ashar BS, Marquart LN. JAMA Dermatol. 2018 Mar 1;154(3):261-263. doi: 10.1001/jamadermatol.2017.5758.
75. Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis. Beaver JA, Hazarika M, Mulkey F, Mushti S, Chen H, He K, Sridhara R, Goldberg KB, Chuk MK, Chi DC, Chang J, Barone A, Balasubramaniam S, Blumenthal GM, Keegan P, Pazdur R, Theoret MR. Lancet Oncol. 2018 Feb;19(2):229-239. doi: 10.1016/S1470-2045(17)30846-X.
76. A multistate investigation of health care-associated Burkholderia cepacia complex infections related to liquid docusate sodium contamination, January-October 2016. Glowicz J, Crist M, Gould C, Moulton-Meissner H, Noble-Wang J, de Man TJB, Perry KA, Miller Z, Yang WC, Langille S, Ross J, Garcia B, Kim J, Epson E, Black S, Pacilli M, LiPuma JJ, Fagan R; B. cepacia Investigation Workgroup. Am J Infect Control. 2018 Jun;46(6):649-655. doi: 10.1016/j.ajic.2017.11.018.
77. Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval. Khozin S, Abernethy AP, Nussbaum NC, Zhi J, Curtis MD, Tucker M, Lee SE, Light DE, Gossai A, Sorg RA, Torres AZ, Patel P, Blumenthal GM, Pazdur R. Oncologist. 2018 Mar;23(3):328-336. doi: 10.1634/theoncologist.2017-0353.
78. The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncology. Cagney DN, Sul J, Huang RY, Ligon KL, Wen PY, Alexander BM. Neuro Oncol. 2018 Aug 2;20(9):1162-1172. doi: 10.1093/neuonc/nox242.
79. FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation. Odogwu L, Mathieu L, Goldberg KB, Blumenthal GM, Larkins E, Fiero MH, Rodriguez L, Bijwaard K, Lee EY, Philip R, Fan I, Donoghue M, Keegan P, McKee A, Pazdur R. Oncologist. 2018 Mar;23(3):353-359. doi: 10.1634/theoncologist.2017-0425.
80. Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections. Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG. Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555.
81. Pediatric Development of Molecularly Targeted Oncology Drugs. Patel SK, Leong R, Zhao H, Barone A, Casey D, Liu Q, Burckart GJ, Reaman G. Clin Pharmacol Ther. 2018 Aug;104(2):384-389. doi: 10.1002/cpt.942.
82. Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma. Ning YM, Maher VE, Beaver JA, Goldberg KB, Blumenthal GM, Pazdur R. Oncologist. 2018 Feb;23(2):139-142. doi: 10.1634/theoncologist.2017-0415.
83. The FDA Oncology Center of Excellence and precision medicine. Goldberg KB, Blumenthal GM, McKee AE, Pazdur R. Exp Biol Med (Maywood). 2018 Feb;243(3):308-312. doi: 10.1177/1535370217740861.
84. A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma. Raju GK, Gurumurthi K, Domike R, Kazandjian D, Landgren O, Blumenthal GM, Farrell A, Pazdur R, Woodcock J. Clin Pharmacol Ther. 2018 Jan;103(1):67-76. doi: 10.1002/cpt.871.