Verified Clinical Benefit | Cancer Accelerated Approvals

Darzalex Faspro (daratumumab and hyaluronidase-fihj)Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients1/15/202111/19/2025Imdelltra (tarlatamab-dlle)Adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy5/16/202411/19/2025Epkinly (epcoritamab-bysp)Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy6/24/202411/18/2025Yervoy (ipilimumab)In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025Opdivo (nivolumab)In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025Vitrakvi (larotrectinib)Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatment11/26/20184/09/2025Opdivo (nivolumab)For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/31/20174/08/2025Opdivo (nivolumab)In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/10/20184/08/2025Yervoy (ipilimumab)In combination with nivolumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/10/20184/08/2025Keytruda (pembrolizumab)In combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma 1 5/5/20213/19/2025Calquence (acalabrutinib)Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy10/31/20171/16/2025Retevmo (selpercatinib)Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy *5/8/20209/27/2024Retevmo (selpercatinib)Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) *5/8/20206/12/2024Tivdak (tisotumab vedotin-tftv)Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy9/20/20214/29/2024Elahere (mirvetuximab soravtansine-gynx)Adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test11/14/20223/22/2024Rybrevant (amivantamab-vmjw)Treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum based chemotherapy5/21/20213/1/2024Tepmetko (tepotinib)Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.2/3/20212/15/2024Keytruda (pembrolizumab)Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib11/9/20181/25/2024Balversa (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. 4/12/20191/19/2024Padcev (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 chemotherapy4/3/202312/15/2023Keytruda (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 chemotherapy4/3/202312/15/2023Keytruda (pembrolizumab) Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)12/19/201810/12/2023Bavencio (avelumab)Treatment of adults and pediatrics patients 12 years and older with metastatic merkel cell carcinoma (MCC)3/23/20179/6/2023Gavreto (pralsetinib)Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test9/4/20208/9/2023Blincyto (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 3/29/20186/20/2023Libtayo (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 appropriate2/9/20214/28/2023Polivy (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.6/10/20194/19/2023Keytruda (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 irinotecan5/23/20173/28/2023Jemperli (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.4/22/20212/9/2023Scemblix (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)10/29/202110/12/2022Retevmo (selpercatinib)Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC) 5/8/202009/21/2022Tabrecta (capmatinib) Adult patients with mNSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test5/6/20208/10/2022Clolar (clofarabine)Treatment of pediatric patients 1 to 21 yrs old with relapsed or refractory acute lymphocytic leukemia (ALL) after at least 2 prior regimens12/28/20047/18/2022Enhertu (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 12/20/20195/4/2022Keytruda (pembrolizumab)In combination with chemotherapy for locally recurrent unresectable or metastatic TNBC expressing PD L1 [CPS =10] as determined by an FDA-approved test11/13/20207/26/2021Trodelvy (sacituzumab govitecan-hziy)Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease4/22/20204/7/2021Padcev (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 setting12/18/20197/9/2021Keytruda (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 radiation9/17/20197/21/2021Lenvima (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 radiation9/17/20197/21/2021Xpovio (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 antibody7/3/201912/18/2020Venclexta (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 chemotherapy11/21/201810/16/2020Lorbrena (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 disease11/2/20183/3/2021Keytruda (pembrolizumab)Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapy6/13/201810/14/2020Keytruda (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 test6/12/201810/13/2021Alimta (pemetrexed disodium)In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC6/4/20181/30/2019Bosulif (bosutinib)Adults with newly diagnosed chronic phase Philadelphia chromosome positive CML12/19/20175/14/2021Keytruda (pembrolizumab)Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy 5/18/20178/31/2021Keytruda (pembrolizumab)In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLC5/10/20178/20/2018Bavencio (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 chemotherapy5/9/20176/30/2020Alunbrig (brigatinib)Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinib4/28/20175/22/2020Keytruda (pembrolizumab)Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapy3/14/201710/14/2020Opdivo (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 chemotherapy2/2/20178/19/2021Rubraca (rucaparib)Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 12/19/20164/6/2018Keytruda (pembrolizumab)Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy8/5/20166/10/2019Venclexta (venetoclax)Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy4/11/20166/8/2018Opdivo (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 inhibitor1/23/20163/7/2019Alecensa (alectinib)ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib12/11/201511/6/2017Darzalex (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 agent11/16/201511/21/2016Tagrisso (osimertinib)Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapy11/13/20153/30/2017Keytruda (pembrolizumab)Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapy10/2/201510/24/2016Opdivo (nivolumab)In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma9/30/20153/7/2019Ibrance (palbociclib)In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease2/3/20153/31/2017Opdivo (nivolumab)Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor12/22/20143/7/2019Lynparza (olaparib)Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 12/19/20148/17/2017Blincyto (blinatumomab)Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia12/3/20147/11/2017Keytruda (pembrolizumab)Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor9/4/201412/18/2015Zykadia (ceritinib)ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib4/29/20145/26/2017Imbruvica (ibrutinib)Chronic lymphocytic leukemia after at least one prior therapy2/12/20147/28/2014Tafinlar (dabrafenib)In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test1/9/201411/20/2015Mekinist (trametinib)In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test1/8/201411/20/2015Perjeta (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 cancer9/30/201312/20/2017Pomalyst (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 therapy2/8/20134/23/2015Iclusig (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 therapy12/14/201211/28/2016Synribo (omacetaxine mepesuccinate)Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs10/26/20122/10/2014Kyprolis (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 therapy7/20/20121/21/2016Afinitor (everolimus)Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgery4/26/20122/18/2016Xalkori (crizotinib)Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test8/26/201111/20/2013Adcetris (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 candidates8/19/20118/17/2015Adcetris (brentuximab vedotin)Systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimen8/19/20113/20/2018Afinitor (everolimus)Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection10/29/20101/29/2016Sprycel (dasatinib)Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phase10/28/20108/12/2015Tasigna (nilotinib)Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase6/17/20101/27/2015Tykerb (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 indicated1/29/201012/6/2018Arzerra (ofatumumab)Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab10/26/20094/17/2014Avastin (bevacizumab)Progressive glioblastoma following prior therapy5/5/200912/5/2017Gleevec (imatinib mesylate)Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)12/19/20081/31/2012Alimta (pemetrexed disodium)Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapy9/26/20087/2/2009Tasigna (nilotinib)Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)10/29/20071/14/2011Gleevec (imatinib mesylate)Newly diagnosed Philadelphia positive CML in pediatric patients9/27/20064/1/2011Vectibix (panitumumab)EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens9/27/20065/23/2014Sprycel (dasatinib)Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib6/28/20065/21/2009Thalomid (thalidomide)Newly diagnosed multiple myeloma5/25/20066/19/2014Sutent (sunitinib maleate)Advanced renal cell carcinoma1/26/20062/2/2007Femara (letrozole)Postmenopausal women with HR positive early breast cancer12/28/20054/30/2010Arranon (nelarabine)Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens10/28/20057/31/2019Femara (letrozole)Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifen10/29/20044/30/2010Alimta (pemetrexed disodium)As a single agent for locally advanced or metastatic NSCLC after prior chemotherapy8/19/20047/2/2009Erbitux (cetuximab)In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy2/12/20047/6/2012Erbitux (cetuximab)As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy2/12/200410/2/2007Gleevec (imatinib mesylate)Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapy5/20/20039/27/2006Velcade (bortezomib)Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapy5/13/20033/25/2005Gleevec (imatinib mesylate)Newly diagnosed adults with Philadelphia chromosome positive CML12/20/20025/27/2009Arimidex (anastrozole)Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer9/5/20029/16/2005Eloxatin (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 irinotectan8/9/20021/9/2004Gleevec (imatinib mesylate)KIT (CD117) positive unresectable and/or metastatic GIST2/1/20029/26/2008Campath (alemtuzumab)B-cell CLL treated with alkylating agents and failed fludarabine therapy5/7/20019/19/2007Temodar (temozolomide)Adults with refractory anaplastic astrocytoma8/11/19993/15/2005Doxil (doxorubicin hydrochloride)Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy6/28/19991/28/2005Depocyt (cytarabine(liposomal))Intrathecal treatment of lymphomatous meningitis4/1/19994/19/2007Xeloda (capecitabine)Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated4/30/19989/7/2001Camptosar (irinotecan hcl trihydrote)Metastatic colon or rectal carcinoma that progressed following 5-FU therapy6/14/199610/22/1998Taxotere (docetaxel)Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy5/14/19966/22/1998Doxil (doxorubicin hydrochloride)Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapy11/17/19956/10/2008