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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Home
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          Other | Cancer Accelerated ApprovalsResources for Information | Approved Drugs Other | Cancer Accelerated Approvals
  
  	
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    PrintThis 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 1Rozlytrek (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
			OngoingKeytruda (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
			OngoingKeytruda (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.

                                                                                  Content current as of:
      10/23/2023
              
              
Regulated Product(s)
		 DrugsResources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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