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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          Withdrawn | Cancer Accelerated Approvals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


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    PrintThis listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the ongoing or withdrawn AA indication pages for more information.

Drug Name
			Accelerated Approval (AA) Indication
			Accelerated Approval Date
			Traditional Approval DateKeytruda (pembrolizumab)
			Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
			11/9/2018
			1/25/2024Balversa (erdafitinib)
			Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has:

			susceptible FGFR3 or FGFR2 genetic alterations, and
				progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.
			4/12/2019
			1/19/2024Padcev (enfortumab vedotin-efjv)
			In combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy
			4/3/2023
			12/15/2023Keytruda (pembrolizumab)
			In combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy
			4/3/2023
			12/15/2023Keytruda (pembrolizumab)
			Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)
			12/19/2018
			10/12/2023Bavencio (avelumab)
			Treatment of adults and pediatrics patients 12 years and older with metastatic merkel cell carcinoma (MCC)
			3/23/2017
			9/6/2023Gavreto (pralsetinib)
			Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
			9/4/2020
			8/9/2023Blincyto (blinatumomab)
			Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children  1
			3/29/2018
			6/20/2023Libtayo (cemiplimab-rwlc)
			Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
			2/9/2021
			4/28/2023Polivy (polatuzumab  vedotin- piiq)
			In combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
			6/10/2019
			4/19/2023Keytruda (pembrolizumab)
			Treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan
			5/23/2017
			3/28/2023Jemperli (dostarlimab-gxly)
			Adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.
			4/22/2021
			2/9/2023Scemblix (asciminib)
			Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
			10/29/2021
			10/12/2022Retevmo (selpercatinib)
			Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)
			5/8/2020
			09/21/2022Tabrecta (capmatinib)
			Adult patients with mNSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test
			5/6/2020
			8/10/2022Clolar (clofarabine)
			Treatment of pediatric patients 1 to 21 yrs old with relapsed or refractory acute lymphocytic leukemia (ALL) after at least 2 prior regimens
			12/28/2004
			7/18/2022Enhertu (Fam-trastuzumab deruxtecan-nxki)
			Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting
			12/20/2019
			5/4/2022Keytruda (pembrolizumab)
			In combination with chemotherapy for locally recurrent unresectable or metastatic TNBC expressing PD L1 [CPS =10] as determined by an FDA-approved test
			11/13/2020
			7/26/2021Trodelvy (sacituzumab govitecan-hziy)
			Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease
			4/22/2020
			4/7/2021Padcev (enfortumab vedotin-ejfv)
			Adults with locally advanced or metastatic urothelial cancer who received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, locally advanced, or metastatic setting
			12/18/2019
			7/9/2021Keytruda (pembrolizumab)
			In combination with lenvatinib for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation
			9/17/2019
			7/21/2021Lenvima (lenvatinib)
			In combination with pembrolizumab for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation
			9/17/2019
			7/21/2021Xpovio (selinexor)
			In combination with dexamethasone for adults with relapsed/refractory multiple myeloma after at least 4 prior therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody
			7/3/2019
			12/18/2020Venclexta (venetoclax)
			In combination with azacitidine or decitabine or low-dose cytarabine for newly-diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
			11/21/2018
			10/16/2020Lorbrena (lorlatinib)
			ALK-positive metastatic NSCLC that has progressed on:
			• Crizotinib and at least one other ALK inhibitor for metastatic disease; or
			• Alectinib as the first ALK inhibitor therapy for metastatic disease; or
			• Ceritinib as the first ALK inhibitor therapy for metastatic disease
			11/2/2018
			3/3/2021Keytruda (pembrolizumab)
			Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapy
			6/13/2018
			10/14/2020Keytruda (pembrolizumab)
			Treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >/=1) as determined by an FDA approved test
			6/12/2018
			10/13/2021Alimta (pemetrexed disodium)
			In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC
			6/4/2018
			1/30/2019Bosulif (bosutinib)
			Adults with newly diagnosed chronic phase Philadelphia chromosome positive CML
			12/19/2017
			5/14/2021Keytruda (pembrolizumab)
			Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy  1
			5/18/2017
			8/31/2021Keytruda (pembrolizumab)
			In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLC
			5/10/2017
			8/20/2018Bavencio (avelumab)
			Locally advanced or metastatic urothelial carcinoma following diease progression on platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
			5/9/2017
			6/30/2020Alunbrig (brigatinib)
			Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinib
			4/28/2017
			5/22/2020Keytruda (pembrolizumab)
			Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapy
			3/14/2017
			10/14/2020Opdivo (nivolumab)
			Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy
			2/2/2017
			8/19/2021Rubraca (rucaparib)
			Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies  2
			12/19/2016
			4/6/2018Keytruda (pembrolizumab)
			Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy
			8/5/2016
			6/10/2019Venclexta (venetoclax)
			Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy
			4/11/2016
			6/8/2018Opdivo (nivolumab)
			1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor
			1/23/2016
			3/7/2019Alecensa (alectinib)
			ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib
			12/11/2015
			11/6/2017Darzalex (daratumumab)
			Multiple myeloma after at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agent
			11/16/2015
			11/21/2016Tagrisso (osimertinib)
			Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapy
			11/13/2015
			3/30/2017Keytruda (pembrolizumab)
			Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapy
			10/2/2015
			10/24/2016Opdivo (nivolumab)
			In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma
			9/30/2015
			3/7/2019Ibrance (palbociclib)
			In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease
			2/3/2015
			3/31/2017Opdivo (nivolumab)
			Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
			12/22/2014
			3/7/2019Lynparza (olaparib)
			Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 2
			12/19/2014
			8/17/2017Blincyto (blinatumomab)
			Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
			12/3/2014
			7/11/2017Keytruda (pembrolizumab)
			Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
			9/4/2014
			12/18/2015Zykadia (ceritinib)
			ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib
			4/29/2014
			5/26/2017Imbruvica (ibrutinib)
			Chronic lymphocytic leukemia after at least one prior therapy
			2/12/2014
			7/28/2014Tafinlar (dabrafenib)
			In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
			1/9/2014
			11/20/2015Mekinist (trametinib)
			In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
			1/8/2014
			11/20/2015Perjeta (pertuzumab)
			In combination with trastuzumab and docetaxel for neoadjuvant treatment of HER2-positive locally advanced inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early early breast cancer
			9/30/2013
			12/20/2017Pomalyst (pomalidomide)
			Multiple myeloma after at least 2 prior therapies including lenalidomide and bortezomib and disease progression on or within  60 days of completion of the last therapy
			2/8/2013
			4/23/2015Iclusig (ponatinib)
			Adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia resistant or intolerant to TKI therapy or or Philadelphia chromosome positive acute lymphoblastic leukemia resistant or intolerant to prior TKI therapy
			12/14/2012
			11/28/2016Synribo (omacetaxine mepesuccinate)
			Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs
			10/26/2012
			2/10/2014Kyprolis (carfilzomib)
			Multiple myeloma after at least 2 prior therapies including bortezomib and an immunomodulatory agent and disease progression on or within 60 days of completion of the last therapy
			7/20/2012
			1/21/2016Afinitor (everolimus)
			Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgery
			4/26/2012
			2/18/2016Xalkori (crizotinib)
			Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test
			8/26/2011
			11/20/2013Adcetris (brentuximab  vedotin)
			Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT), or after failure of at least 2 multi-agent chemotherapy regimens in patients who are not ASCT candidates
			8/19/2011
			8/17/2015Adcetris (brentuximab  vedotin)
			Systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimen
			8/19/2011
			3/20/2018Afinitor (everolimus)
			Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection
			10/29/2010
			1/29/2016Sprycel (dasatinib)
			Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phase
			10/28/2010
			8/12/2015Tasigna (nilotinib)
			Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase
			6/17/2010
			1/27/2015Tykerb (lapatinib)
			In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated
			1/29/2010
			12/6/2018Arzerra (ofatumumab)
			Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab
			10/26/2009
			4/17/2014Avastin (bevacizumab)
			Progressive glioblastoma following prior therapy
			5/5/2009
			12/5/2017Gleevec (imatinib mesylate)
			Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)
			12/19/2008
			1/31/2012Alimta (pemetrexed disodium)
			Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapy
			9/26/2008
			7/2/2009Tasigna (nilotinib)
			Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)
			10/29/2007
			1/14/2011Gleevec (imatinib mesylate)
			Newly diagnosed Philadelphia positive CML in pediatric patients
			9/27/2006
			4/1/2011Vectibix (panitumumab)
			EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens
			9/27/2006
			5/23/2014Sprycel (dasatinib)
			Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib
			6/28/2006
			5/21/2009Thalomid (thalidomide)
			Newly diagnosed multiple myeloma
			5/25/2006
			6/19/2014Sutent (sunitinib maleate)
			Advanced renal cell carcinoma
			1/26/2006
			2/2/2007Femara (letrozole)
			Postmenopausal women with HR positive early breast cancer
			12/28/2005
			4/30/2010Arranon (nelarabine)
			Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens
			10/28/2005
			7/31/2019Femara (letrozole)
			Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifen
			10/29/2004
			4/30/2010Alimta (pemetrexed disodium)
			As a single agent for locally advanced or metastatic NSCLC after prior chemotherapy
			8/19/2004
			7/2/2009Erbitux (cetuximab)
			In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy
			2/12/2004
			7/6/2012Erbitux (cetuximab)
			As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy
			2/12/2004
			10/2/2007Gleevec (imatinib mesylate)
			Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapy
			5/20/2003
			9/27/2006Velcade (bortezomib)
			Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapy
			5/13/2003
			3/25/2005Gleevec (imatinib mesylate)
			Newly diagnosed adults with Philadelphia chromosome positive CML
			12/20/2002
			5/27/2009Arimidex (anastrozole)
			Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
			9/5/2002
			9/16/2005Eloxatin (oxaliplatin)
			In combination with infusional 5-FU/LV for metastatic color or rectal carcinoma that progressed during or within 6 months of completion of first-line therapy with bolus 5 -FU/LV and irinotectan
			8/9/2002
			1/9/2004Zevalin (ibritumomab tiuxetan)
			Relapsed or refractory low-grade follicular or transformed B-cell NHL other than rituximab-refractory follicular NHL
			2/19/2002
			9/3/2009Gleevec (imatinib mesylate)
			KIT (CD117) positive unresectable and/or metastatic GIST
			2/1/2002
			9/26/2008Gleevec (imatinib mesylate)
			CML in blast crisis, accelerated phase, or in chronic phase after failure of of interferon-alpha
			5/10/2001
			12/8/2003Campath (alemtuzumab)
			B-cell CLL treated with alkylating agents and failed fludarabine therapy
			5/7/2001
			9/19/2007Temodar (temozolomide)
			Adults with refractory anaplastic astrocytoma
			8/11/1999
			3/15/2005Doxil (doxorubicin hydrochloride)
			Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy
			6/28/1999
			1/28/2005Ontak (denileukin diftitox)
			Persistent or recurrent cutaneous T-cell lymphoma expressing the CD25 component of IL-2 receptor
			2/5/1999
			10/15/2008Depocyt (cytarabine(liposomal))
			Intrathecal treatment of lymphomatous meningitis
			4/1/1999
			4/19/2007Xeloda (capecitabine)
			Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated
			4/30/1998
			9/7/2001Camptosar (irinotecan hcl trihydrote)
			Metastatic colon or rectal carcinoma that progressed following 5-FU therapy
			6/14/1996
			10/22/1998Taxotere (docetaxel)
			Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy
			5/14/1996
			6/22/1998Doxil (doxorubicin hydrochloride)
			Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapy
			11/17/1995
			6/10/2008Casodex (bicalutamide)
			In combination with an LHRH analogue for advanced prostate cancer
			10/4/1995
			12/12/1997


1
              a
                      b
                    The original AA indication was modified to include a restricted population.
                                      2
              a
                      b
                    This indication was subsequently withdrawn after traditional approval was granted based on post-marketing data.

                                                                                  Content current as of:
      01/29/2024
              
              
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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