Other | Cancer Accelerated Approvals - Pill Pals®

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
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
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Formulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy	3/13/2020	Withdrawn (12/08/2021)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)