Other | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
Drug Name | Accelerated Approval Indication | Accelerated Approval Date | Current Status 1 |
---|---|---|---|
Keytruda (pembrolizumab) |
Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with melanoma, hepatocellular carcinoma, Merkel cell carcinoma, gastric cancer, non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, cervical carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, small cell lung cancer, esophageal cancer, microsatellite instability-high or mismatch repair deficient solid tumors |
4/28/2020 |
Traditional Approval Granted (12/16/2022) |
Keytruda (pembrolizumab) |
Dosing Regimen: Alternative dose/schedule of 400 mg every 6 weeks for adult patients with classical Hodgkin lymphoma and primary mediastinal b-cell lymphoma |
4/28/2020 |
Ongoing |
Keytruda (pembrolizumab) |
Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with cutaneous squamous cell carcinoma |
6/24/2020 |
Traditional Approval Granted (12/16/2022) |
Romidepsin |
Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy |
3/13/2020 |
Withdrawn (12/08/2021) |
Zinecard (dexrazoxane hydrochloride) |
Supportive Care: Prevention of cardiomyopathy associated with doxorubicin administration |
5/26/1995 |
Traditional Approval Granted (10/31/2002) |
Keytruda (pembrolizumab) |
Dosing Regimen: Alternate Dose/Schedule of 400 mg every 6 weeks for adult patients with unresectable or metastatic tumor mutational burden high [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options |
6/16/2020 |
Traditional Approval Granted (12/16/2022) |
Afinitor Disperz (everolimus) |
Formulation: Pediatric and adult patients with tuberous sclerosis complex for treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected |
8/29/2012 |
Traditional Approval Granted (01/29/2016) |
- 1. Withdrawal date indicates either the effective date published by the Federal Register or the date the product label was updated, whichever date came first.