2022 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
|---|---|---|---|---|
| BREYANZI lisocabtagene maraleucel |
To support two new indications for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large Bcell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: • refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or • refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. |
125714/90 | Juno Therapeutics, Inc. a Bristol-Myers Squibb Company 86 Morris Ave Summit, NJ 07901 Lic. # 2156 |
06/24/2022 |
| VAXNEUVANCE Pneumococcal 15-valent Conjugate Vaccinel |
To include results from 7 clinical studies (V114-008, V114-023, V114-024, V114-027, V114-029, V114-030, and V114-031) conducted in children 6 weeks through 17 years of age and to fulfill PREA PMRs #1, #2, #3, #4. | 125741/6 | Merck Sharp and Dohme Corp. 351 N. Sumneytown Pike North Wales, PA Lic. # 0002 |
06/17/2022 |
| KYMRIAH Tisagenlecleucel |
To add a new indication for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy, and to include a major modification to the approved Risk Evaluation and Mitigation Strategy (REMS), according to [21 CFR 601.41]. | 125646/663 | Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936 Lic. # 1244 |
05/27/2022 |
| YESCARTA axicabtagene ciloleucel |
To add a new indication for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma. | 125643/394 | Kite Pharma, Inc. 2400 Broadway Santa Monica, CA 90404 Lic. # 2064 |
04/01/2022 |
| VONVENDI von Willebrand factor (Recombinant) |
To update the US Prescribing Information to expand the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults diagnosed with severe Type 3 von Willebrand Disease receiving on-demand therapy | 125577/412 | Baxalta US Inc. 300 Shire Way Lexington, MA 02421 Lic. # 2020 |
01/28/2022 |