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 In this section:

                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          Withdrawn | Cancer Accelerated Approvals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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          Withdrawn | Cancer Accelerated ApprovalsResources for Information | Approved Drugs Withdrawn | Cancer Accelerated Approvals
  
  	
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    PrintThis listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the ongoing or verified AA indication pages for more information.

**Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.**

Drug Name
			Accelerated Approval (AA) Indication
			Accelerated Approval Date
			Withdrawal Date 1Gavreto (pralsetinib)
			Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
			12/1/2020
			7/20/2023Imbruvica (ibrutinib)
			Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
			11/13/2013
			5/18/2023Imbruvica (ibrutinib)
			Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy
			1/18/2017
			5/18/2023Blenrep (belantamab mafodotin-blmf)
			Adults patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
			8/5/2020
			2/6/2023Tecentriq (atezolizumab)
			Patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 as determined by an FDA approved test or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
			4/17/2017
			12/2/2022Ukoniq (umbralisib)
			Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20- based regimen
			2/5/2021
			5/31/2022Ukoniq (umbralisib)
			Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy
			2/5/2021
			5/31/2022Marqibo (vincristine sulfate liposomal)
			Adults with Philadelphia (PH) chromosome negative (-) ALL in second relapse or greater relapsed or whose disease has progressed following 2 or greater treatment lines of anti-leukemia therapies
			8/9/2012
			5/2/2022Farydak (panobinostat)
			In combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior regimens, including BTZ and an immunomodulatory agent.
			2/23/2015
			3/24/2022Zydelig (idelalisib)
			For the treatment of relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) in patients who have received at least 2 prior systemic therapies and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies
			7/23/2014
			2/18/2022Keytruda (pembrolizumab)
			For patients with recurrent or locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by an FDA-approved test, with disease progression on/after two or more prior lines of therapy including fluoropyrimidine and platinum containing chemotherapy and if appropriate, HER2/NEU targeted therapy
			9/22/2017
			2/4/2022Copiktra (duvelisib)
			Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies
			9/24/2018
			12/17/2021Keytruda (pembrolizumab)
			Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
			6/17/2019
			3/30/2021Tecentriq (atezolizumab)
			In combination with paclitaxel protein-bound for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test.
			3/8/2019
			10/6/2021Opdivo (nivolumab)
			Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy
			8/16/2018
			12/29/2020Opdivo (nivolumab)
			Hepatocellular carcinoma previously treated with sorafenib
			9/22/2017
			7/23/2021Imfinzi (durvalumab)
			Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
			5/1/2017
			2/19/2021Lartruvo (olaratumab)
			In combination with doxorubicin for adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery
			10/19/2016
			2/25/2020Tecentriq (atezolizumab)
			Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
			5/18/2016
			4/13/2021Istodax (romidepsin)
			Peripheral T-cell lymphoma in patients who have received at least one prior therapy
			6/16/2011
			7/30/2021Oforta (fludarabine phosphate)
			For adults with B-cell CLL that has not responded to or progressed during or after treatment with at least one standard alkylating agent containing regimen
			12/18/2008
			12/31/2011Avastin (bevacizumab)
			In combination with paclitaxel for patients who have not received chemotherapy for metastatic HER2 negative breast cancer
			2/22/2008
			11/18/2011Bexxar (tositumomab and iodine i 131 tositumomab)
			For patients with relapsed or refractory low-grade follicular or transformed CD20+ NHL who have not received rituximab
			12/22/2004
			10/23/2013Iressa (gefitinib)
			As monotherapy for locally advanced or metastatic NSCLC after failure of platinum-based and docetaxel chemotherapy
			5/5/2003
			4/25/2012Mylotarg (gemtuzumab ozogamicin)
			For patients with CD33+ AML in first relapse 60 years of age or older and not candidates for cytotoxic chemotherapy
			5/17/2000
			11/28/2011Celebrex (celecoxib)
			To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis patients, as an adjunct to usual care
			12/23/1999
			6/8/2012


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:
      07/25/2023
              
              
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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