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  1. Resources for Information | Approved Drugs

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
Vijoice (alpelisib) Formulation: Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. 04/24/2024 Ongoing
RETEVMO (selpercatinib) Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy 04/10/2024 Traditional Approval Granted (09/27/2024
RETEVMO (selpercatinib) Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) 04/10/2024 Traditional Approval Granted (06/12/2024)
RETEVMO (selpercatinib) Formulation: Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options 04/10/2024 Ongoing
Rozlytrek (entrectinib)

Formulation: Adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation as detected by an FDA-approved test, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy.

 10/20/2023 Ongoing

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)
  • 1Withdrawal date indicates either the effective date published by the Federal Register or the date the product label was updated, whichever date came first.
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