Jayprica (pirtobrutinib)Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor12/1/202312/3/2025 Darzalex Faspro (daratumumab and hyaluronidase-fihj)[Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-a…
Jayprica (pirtobrutinib)Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor12/1/202312/3/2025 Darzalex Faspro (daratumumab and hyaluronidase-fihj)Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients1/15/202111/19/2025 Imdelltra (tarlatamab-dlle)Adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy5/16/202411/19/2025 Epkinly (epcoritamab-bysp)Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy6/24/202411/18/2025 Yervoy (ipilimumab)In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025 Opdivo (nivolumab)In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025 Vitrakvi (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 treatment11/26/20184/09/2025 Opdivo (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 irinotecan7/31/20174/08/2025 Opdivo (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 irinotecan7/10/20184/08/2025 Yervoy (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 irinotecan7/10/20184/08/2025 Keytruda (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 5/5/20213/19/2025 Calquence (acalabrutinib)Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy10/31/20171/16/2025 Retevmo (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 *5/8/20209/27/2024 Retevmo (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) *5/8/20206/12/2024 Tivdak (tisotumab vedotin-tftv)Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy9/20/20214/29/2024 Elahere (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 test11/14/20223/22/2024 Rybrevant (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 chemotherapy5/21/20213/1/2024 Tepmetko (tepotinib)Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.2/3/20212/15/2024 Keytruda (pembrolizumab)Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib11/9/20181/25/2024 Balversa (erdafitinib)
- 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. 4/12/20191/19/2024 Padcev (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 chemotherapy4/3/202312/15/2023 Keytruda (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 chemotherapy4/3/202312/15/2023 Keytruda (pembrolizumab) Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)12/19/201810/12/2023 Bavencio (avelumab)Treatment of adults and pediatrics patients 12 years and older with metastatic merkel cell carcinoma (MCC)3/23/20179/6/2023 Gavreto (pralsetinib)Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test9/4/20208/9/2023 Blincyto (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 13/29/20186/20/2023 Libtayo (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 appropriate2/9/20214/28/2023 Polivy (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.6/10/20194/19/2023 Keytruda (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 irinotecan5/23/20173/28/2023 Jemperli (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.4/22/20212/9/2023 Scemblix (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)10/29/202110/12/2022 Retevmo (selpercatinib)Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC) 5/8/202009/21/2022 Tabrecta (capmatinib) Adult patients with mNSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test5/6/20208/10/2022 Clolar (clofarabine)Treatment of pediatric patients 1 to 21 yrs old with relapsed or refractory acute lymphocytic leukemia (ALL) after at least 2 prior regimens12/28/20047/18/2022 Enhertu (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 12/20/20195/4/2022 Keytruda (pembrolizumab)In combination with chemotherapy for locally recurrent unresectable or metastatic TNBC expressing PD L1 [CPS =10] as determined by an FDA-approved test11/13/20207/26/2021 Trodelvy (sacituzumab govitecan-hziy)Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease4/22/20204/7/2021 Padcev (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 setting12/18/20197/9/2021 Keytruda (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 radiation9/17/20197/21/2021 Lenvima (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 radiation9/17/20197/21/2021 Xpovio (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 antibody7/3/201912/18/2020 Venclexta (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 chemotherapy11/21/201810/16/2020 Lorbrena (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 disease11/2/20183/3/2021 Keytruda (pembrolizumab)Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapy6/13/201810/14/2020 Keytruda (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 test6/12/201810/13/2021 Alimta (pemetrexed disodium)In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC6/4/20181/30/2019 Bosulif (bosutinib)Adults with newly diagnosed chronic phase Philadelphia chromosome positive CML12/19/20175/14/2021 Keytruda (pembrolizumab)Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy 15/18/20178/31/2021 Keytruda (pembrolizumab)In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLC5/10/20178/20/2018 Bavencio (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 chemotherapy5/9/20176/30/2020 Alunbrig (brigatinib)Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinib4/28/20175/22/2020 Keytruda (pembrolizumab)Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapy3/14/201710/14/2020 Opdivo (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 chemotherapy2/2/20178/19/2021 Rubraca (rucaparib)Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 212/19/20164/6/2018 Keytruda (pembrolizumab)Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy8/5/20166/10/2019 Venclexta (venetoclax)Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy4/11/20166/8/2018 Opdivo (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 inhibitor1/23/20163/7/2019 Alecensa (alectinib)ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib12/11/201511/6/2017 Darzalex (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 agent11/16/201511/21/2016 Tagrisso (osimertinib)Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapy11/13/20153/30/2017 Keytruda (pembrolizumab)Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapy10/2/201510/24/2016 Opdivo (nivolumab)In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma9/30/20153/7/2019 Ibrance (palbociclib)In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease2/3/20153/31/2017 Opdivo (nivolumab)Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor12/22/20143/7/2019 Lynparza (olaparib)Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 212/19/20148/17/2017 Blincyto (blinatumomab)Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia12/3/20147/11/2017 Keytruda (pembrolizumab)Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor9/4/201412/18/2015 Zykadia (ceritinib)ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib4/29/20145/26/2017 Imbruvica (ibrutinib)Chronic lymphocytic leukemia after at least one prior therapy2/12/20147/28/2014 Tafinlar (dabrafenib)In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test1/9/201411/20/2015 Mekinist (trametinib)In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test1/8/201411/20/2015 Perjeta (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 cancer9/30/201312/20/2017 Pomalyst (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 therapy2/8/20134/23/2015 Iclusig (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 therapy12/14/201211/28/2016 Synribo (omacetaxine mepesuccinate)Adults with chronic or accelerated phase chronic myeloid leukemia with resistance or intolerance to 2 or more TKIs10/26/20122/10/2014 Kyprolis (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 therapy7/20/20121/21/2016 Afinitor (everolimus)Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgery4/26/20122/18/2016 Xalkori (crizotinib)Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test8/26/201111/20/2013 Adcetris (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 candidates8/19/20118/17/2015 Adcetris (brentuximab vedotin)Systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimen8/19/20113/20/2018 Afinitor (everolimus)Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection10/29/20101/29/2016 Sprycel (dasatinib)Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phase10/28/20108/12/2015 Tasigna (nilotinib)Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase6/17/20101/27/2015 Tykerb (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 indicated1/29/201012/6/2018 Arzerra (ofatumumab)Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab10/26/20094/17/2014 Avastin (bevacizumab)Progressive glioblastoma following prior therapy5/5/200912/5/2017 Gleevec (imatinib mesylate)Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)12/19/20081/31/2012 Alimta (pemetrexed disodium)Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapy9/26/20087/2/2009 Tasigna (nilotinib)Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)10/29/20071/14/2011 Gleevec (imatinib mesylate)Newly diagnosed Philadelphia positive CML in pediatric patients9/27/20064/1/2011 Vectibix (panitumumab)EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens9/27/20065/23/2014 Sprycel (dasatinib)Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib6/28/20065/21/2009 Thalomid (thalidomide)Newly diagnosed multiple myeloma5/25/20066/19/2014 Sutent (sunitinib maleate)Advanced renal cell carcinoma1/26/20062/2/2007 Femara (letrozole)Postmenopausal women with HR positive early breast cancer12/28/20054/30/2010 Arranon (nelarabine)Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens10/28/20057/31/2019 Femara (letrozole)Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifen10/29/20044/30/2010 Alimta (pemetrexed disodium)As a single agent for locally advanced or metastatic NSCLC after prior chemotherapy8/19/20047/2/2009 Erbitux (cetuximab)In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy2/12/20047/6/2012 Erbitux (cetuximab)As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy2/12/200410/2/2007 Gleevec (imatinib mesylate)Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapy5/20/20039/27/2006 Velcade (bortezomib)Multiple myeloma patients who received at least two prior therapies and demontrated disease progression on the last therapy5/13/20033/25/2005 Gleevec (imatinib mesylate)Newly diagnosed adults with Philadelphia chromosome positive CML12/20/20025/27/2009 Arimidex (anastrozole)Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer9/5/20029/16/2005 Eloxatin (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 irinotectan8/9/20021/9/2004 Zevalin (ibritumomab tiuxetan)Relapsed or refractory low-grade follicular or transformed B-cell NHL other than rituximab-refractory follicular NHL2/19/20029/3/2009 Gleevec (imatinib mesylate)KIT (CD117) positive unresectable and/or metastatic GIST2/1/20029/26/2008 Gleevec (imatinib mesylate)CML in blast crisis, accelerated phase, or in chronic phase after failure of of interferon-alpha5/10/200112/8/2003 Campath (alemtuzumab)B-cell CLL treated with alkylating agents and failed fludarabine therapy5/7/20019/19/2007 Temodar (temozolomide)Adults with refractory anaplastic astrocytoma8/11/19993/15/2005 Doxil (doxorubicin hydrochloride)Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy6/28/19991/28/2005 Ontak (denileukin diftitox)Persistent or recurrent cutaneous T-cell lymphoma expressing the CD25 component of IL-2 receptor2/5/199910/15/2008 Depocyt (cytarabine(liposomal))Intrathecal treatment of lymphomatous meningitis4/1/19994/19/2007 Xeloda (capecitabine)Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated4/30/19989/7/2001 Camptosar (irinotecan hcl trihydrote)Metastatic colon or rectal carcinoma that progressed following 5-FU therapy6/14/199610/22/1998 Taxotere (docetaxel)Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy5/14/19966/22/1998 Doxil (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 Casodex (bicalutamide)In combination with an LHRH analogue for advanced prostate cancer10/4/199512/12/1997