Background
FDA-approved therapeutic drugs for lung cancers
Non-small cell lung cancer
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Vinorelbine tartrate (Navelbine) | Pierre Fabre | Microtubule-destabilizing agent | NSCLC | 12/23/1994 | P |
Gefitinib (Iressa) | AstraZeneca | EGFR inhibitor | NSCLC | 05/05/2003 | P |
Erlotinib HCl (Tarceva) | OSI Pharmas | EGFR inhibitor | NSCLC | 11/18/2004 | P |
Afatinib dimaleate (Gilotrif) | Boehringer Ingelheim | EGFR, HER2, and HER4 inhibitor | Metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) mutation | 07/12/2013 | P, O |
Osimertinib mesylate (Tagrisso) | AstraZeneca | EGFR inhibitor | NSCLC with EGFRT790M mutations | 11/13/2015 | P, O |
Dacomitinib (Vizimpro) | Pfizer | EGFR inhibitor | EGFR-mutated NSCLC | 09/27/2018 | P, O |
Necitumumab (Portrazza) | Eli Lilly | EGFR-directed mAb | NSCLC | 11/24/2015 | S, O |
Amivantamab (Rybrevant) | Janssen Biotech | EGFR- and MET-bispecific antibody | EGFR exon 20-mutated NSCLC | 05/21/2021 | P |
Mobocertinib succinate (Exkivity) | Takeda | EGFR inhibitor | EGFR exon 20-mutated NSCLC | 09/15/2021 | P, O |
Crizotinib (Xalkori) | Merck & Co | Multitarget TKI (ALK, ROS1, and MET) | ALK-positive advanced or metastatic NSCLC | 08/26/2011 | P, O |
Ceritinib (Zykadia) | Novartis | Multitarget TKI (ALK, IGF1R, INSR, and ROS1) | ALK-positive metastatic NSCLC | 04/29/2014 | P, O |
Alectinib HCl (Alecensa) | Roche | ALK inhibitor | NSCLC | 12/11/2015 | P, O |
Brigatinib (Alunbrig) | Takeda | Multitarget TKI (ALK, EGFR, IGF1R, FLT3, and ROS1) | ALK-positive NSCLC | 04/28/2017 | P, O |
Lorlatinib (Lorbrena) | Pfizer | Multitarget TKI (ALK and ROS1) | ALK-positive NSCLC | 11/02/2018 | P, O |
Capmatinib HCl (Tabrecta) | Novartis | MET inhibitor | NSCLC | 05/06/2020 | P, O |
Tepotinib HCl (Tepmetko) | Emd Serono | MET inhibitor | NSCLC | 02/03/2021 | P, O |
Selpercatinib (Retevmo) | Loxo Oncology | RET inhibitor | RET fusion-positive NSCLC and thyroid cancer | 05/08/2020 | P, O |
Pralsetinib (Gavreto) | Genentech | RET inhibitor | RET fusion-positive NSCLC | 09/04/2020 | P, O |
Entrectinib (Rozlytrek) | Genentech | Multitarget TKI (TRKs, ROS1, and ALK) | NTRK fusion-positive solid tumors and ROS1-positive NSCLC | 08/15/2019 | P, O |
Sotorasib (Lumakras) | Amgen | KRASG12C inhibitor | KRASG12C-mutated NSCLC | 05/28/2021 | P, O |
Topotecan HCl (Hycamtin) | Novartis | DNA topoisomerases inhibitor | Relapsed SCLC | 05/28/1996 | P |
Lurbinectedin (Zepzelca) | Jazz | DNA alkylating drug | SCLC | 06/15/2020 | P, O |
Small-cell lung cancer
FDA-approved therapeutic drugs for breast cancers
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Docetaxel (Taxotere) | Sanofi | Microtubule-stabilizing agent | Locally advanced or metastatic breast cancer | 05/14/1996 | P |
Ixabepilone (Ixempra) | R-Pharm US | Microtubule-stabilizing agent | Locally advanced or metastatic breast cancer | 10/16/2007 | P |
Eribulin mesylate (Halaven) | Eisai | Microtubule-destabilizing agent | Locally advanced or metastatic breast cancer | 11/15/2010 | P |
Capecitabine (Xeloda) | Roche | A prodrug of 5-FU | Metastatic breast cancer | 04/30/1998 | P |
Epirubicin HCl (Ellence) | Pfizer | DNA topoisomerase II inhibitor | Primary breast cancer with axillary node tumor involvement | 09/15/1999 | P, O |
Anastrozole (Arimidex) | Ani pharms | Aromatase inhibitor | Advanced breast cancer in postmenopausal women | 12/27/1995 | S |
Letrozole (Femara) | Novartis | Aromatase inhibitor | Advanced breast cancer | 07/25/1997 | S |
Exemestane (Aromasin) | Pfizer | Aromatase inhibitor | ER-positive early breast cancer | 10/21/1999 | S, O |
Toremifene citrate (Fareston) | Kyowa Kirin | ER inhibitor | ER-positive metastatic breast cancer | 05/29/1997 | S, O |
Fulvestrant (Faslodex) | AstraZeneca | ER antagonist | HR-positive metastatic breast cancer | 04/25/2002 | S |
Palbociclib (Ibrance) | Pfizer | CDK4/6 inhibitor | HER2-negative and HR-positive advanced or metastatic breast cancer | 02/03/2015 | P |
Ribociclib succinate (Kisqali) | Novartis | CDK4/6 inhibitor | HR-positive, HER2-negative breast cancer | 03/13/2017 | P |
Abemaciclib (Verzenio) | Eli Lilly | CDK4/6 inhibitor | HR-positive, HER2-negative breast cancer | 09/28/2017 | P |
Trastuzumab (Herceptin) | Genentech | HER2-directed mAb | HER2-positive breast cancer | 09/25/1998 | P |
Pertuzumab (Perjeta) | Genentech | HER2‑directed mAb | HER2‑positive metastatic breast cancer | 06/08/2012 | P |
Margetuximab (Margenza) | MacroGenics | HER2-directed mAb | HER2-positive breast cancer | 12/16/2020 | S |
Ado-trastuzumab emtansine (Kadcyla) | Genentech | HER2‑directed ADC | HER2‑positive metastatic breast cancer | 02/22/2013 | P |
Trastuzumab deruxtecan (Enhertu) | Daiichi Sankyo | HER2-directed ADC | HER2-positive breast cancer | 12/20/2019 | P |
Lapatinib ditosylate (Tykerb) | Novartis | HER2 and EGFR inhibitor | Advanced or metastatic breast cancer | 03/13/2007 | P |
Neratinib maleate (Nerlynx) | Puma Biotech | EGFR, HER2, and HER4 inhibitor | HER2-overexpressed breast cancer | 07/17/2017 | S |
Tucatinib (Tukysa) | Seagen | HER2 inhibitor | HER2-positive breast cancer | 04/17/2020 | P, O |
Talazoparib tosylate (Talzenna) | Pfizer | PARP inhibitor | BRCA-mutated HER2-negative breast cancer | 10/16/2018 | P |
Alpelisib (Piqray) | Novartis | PI3Kα inhibitor | PIK3CA-altered, HR-positive, and HER2-negative breast cancer | 05/24/2019 | P |
Sacituzumab govitecan (Trodelvy) | Immunomedics | Trop-2-directed ADC | Triple-negative breast cancer (TNBC) | 04/22/2020 | P |
Cytotoxic drugs for breast cancer
ER- or HR-positive breast cancer
HER2-positive breast cancer
BRCA-mutated breast cancer
PIK3CA-altered breast cancer
Triple-negative breast cancer
FDA-approved therapeutic drugs for gynecologic cancers
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Paclitaxel (Taxol) | HQ Spclt | Microtubule-stabilizing agent | Advanced ovarian cancer | 12/29/1992 | P, O |
Olaparib (Lynparza) | AstraZeneca | PARP inhibitor | Advanced BRCA-mutated ovarian cancer | 12/19/2014 | P, O |
Rucaparib camsylate (Rubraca) | Clovis Oncology | PARP inhibitor | BRCA-positive ovarian cancer | 12/19/2016 | P, O |
Niraparib tosylate (Zejula) | GlaxoSmithKline | PARP inhibitor | Epithelial ovarian, fallopian tube, or primary peritoneal cancer | 03/27/2017 | P, O |
Dostarlimab (Jemperli) | GlaxoSmithKline | PD1-directed mAb | Endometrial cancer | 04/22/2021 | P |
Tisotumab vedotin (Tivdak) | Seagen | TF-targeted ADC | Cervical cancer | 09/20/2021 | P, O |
Ovarian cancer
Endometrial cancer
Cervical cancer
FDA-approved therapeutic drugs for gastrointestinal cancers
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Porfimer sodium (Photofrin) | Pinnacle Biolgs | A photosensitizer used for photodynamic therapy | Obstructing esophageal cancer | 12/27/1995 | P, O |
Ramucirumab (Cyramza) | Eli Lilly | VEGFR2-directed mAb | Gastric cancer | 04/21/2014 | P, O |
Sunitinib malate (Sutent) | CPPI CV | Multitarget TKI (VEGFRs, PDGFRα/β, CSF1R, KIT, and FLT3) | Imatinib-resistant GIST and advanced RCC | 01/26/2006 | P |
Avapritinib (Ayvakit) | Blueprint | PDGFRα, PDGFRα mutants, and KIT inhibitor | GIST with PDGFRA exon 18 mutations | 01/09/2020 | P, O |
Ripretinib (Qinlock) | Deciphera | PDGFRα, PDGFRα mutants, and KIT inhibitor | Advanced GIST | 05/15/2020 | P, O |
Lutetium Lu-177 dotatate (Lutathera) | AAA USA | Somatostatin receptor-targeted radiopharmaceutical | GEP-NETs | 01/26/2018 | P, O |
Pemigatinib (Pemazyre) | Incyte | FGFR1-3 inhibitor | Advanced cholangiocarcinoma with FGFR2 fusions/rearrangements | 04/17/2020 | P, O |
Infigratinib phosphate (Truseltiq) | Helsinn Hlthcare | FGFR1-3 inhibitor | Advanced cholangiocarcinoma with FGFR2 fusions/rearrangements | 05/28/2021 | P, O |
Gemcitabine HCl (Gemzar) | Eli Lilly | DNA synthesis inhibitor | Locally advanced or metastatic pancreatic cancer | 05/15/1996 | P |
Irinotecan HCl (Camptosar) | Pfizer | DNA topoisomerase I inhibitor | Metastatic colorectal cancer | 06/14/1996 | P |
Oxaliplatin (Eloxatin) | Sanofi | Organoplatinum alkylating agent | Colorectal cancer (in combination with 5-FU and leucovorin) | 08/09/2002 | P |
Cetuximab (Erbitux) | ImClone | EGFR‑directed mAb | Colorectal cancer | 02/12/2004 | N/A |
Panitumumab (Vectibix) | Amgen | EGFR‑directed mAb | Colorectal cancer | 09/27/2006 | N/A |
Bevacizumab (Avastin) | Genentech | VEGF‑A-directed mAb | Colorectal cancer | 02/26/2004 | O |
Ziv-aflibercept (Zaltrap) | Sanofi | Soluble receptor decoy that binds VEGF-A, VEGF-B, and PlGF | Metastatic colorectal cancer | 08/03/2012 | N/A |
Regorafenib (Stivarga) | Bayer | Multitarget TKI (RET, VEGFRs, KIT, PDGFRα/β, FGFR1/2, RAF1, BRAF, and BRAFV600E) | Metastatic colorectal cancer | 09/27/2012 | P |
Tipiracil HCl; Trifluridine (Lonsurf) | Taiho | Thymidine phosphorylase inhibitor plus a nucleoside metabolic inhibitor | Colorectal cancer | 09/22/2015 | S |
Esophageal cancer
Gastric cancer
Gastrointestinal stromal tumors
Gastroenteropancreatic neuroendocrine tumors
Cholangiocarcinoma
Pancreatic cancer
Colorectal cancer
FDA-approved therapeutic drugs for prostate cancers
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Bicalutamide (Casodex) | Ani pharms | AR antagonist | Advanced prostate cancer | 10/04/1995 | S |
Nilutamide (Nilandron) | Concordia | AR antagonist | Metastatic prostate cancer | 09/19/1996 | S |
Enzalutamide (Xtandi) | Astellas | AR antagonist | mCRPC | 08/31/2012 | P |
Apalutamide (Erleada) | Janssen | AR antagonist | Prostate cancer | 02/14/2018 | P |
Darolutamide (Nubeqa) | Bayer | AR antagonist | Prostate cancer | 7/30/2019 | P |
Triptorelin pamoate (Trelstar) | Verity | GnRH agonist | Advanced prostate cancer | 06/15/2000 | S |
Abarelix (Plenaxis) | Speciality | GnRH receptor antagonist | Advanced prostate cancer | 11/25/2003 | P |
Degarelix acetate (Firmagon) | Ferring | GnRH receptor antagonist | Advanced prostate cancer | 12/24/2008 | S |
Relugolix (Orgovyx) | Myovant | GnRH receptor antagonist | Prostate cancer | 12/18/2020 | P |
Cabazitaxel (Jevtana kit) | Sanofi | Microtubule-stabilizing agent | Prostate cancer | 06/17/2010 | P |
Abiraterone acetate (Zytiga) | Janssen | CYP17A1 inhibitor | mCRPC | 04/28/2011 | P |
Radium RA 223 dichloride (Xofigo) | Bayer | α-particle-emitting radiopharmaceutical | mCRPC | 05/15/2013 | P |
FDA-approved therapeutic drugs for urologic cancers
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Aldesleukin (Proleukin) | Chiron | Recombinant human interleukin-2 | Metastatic RCC | 05/05/1992 | O |
Sorafenib toylate (Nexavar) | Bayer | Multitarget TKI (VEGFR2/3, PDGFRβ, FLT3, KIT, RAF1, and BRAF) | Advanced RCC | 12/01/2005 | P, O |
Pazopanib HCl (Votrient) | Novartis | Multitarget TKI (VEGFRs, PDGFRα/β, FGFR1/2, KIT) | Metastatic RCC | 10/19/2009 | S |
Axitinib (Inlyta) | Pfizer | VEGFRs inhibitor | Advanced RCC | 01/27/2012 | S |
Tivozanib HCl (Fotivda) | Aveo Pharms | VEGFRs inhibitor | Advanced RCC | 03/10/2021 | S |
Temsirolimus (Torisel) | Merck & Co | mTOR inhibitor | Advanced RCC | 05/30/2007 | P |
Everolimus (Afinitor) | Novartis | mTOR inhibitor | Advanced RCC | 03/30/2009 | P |
Atezolizumab (Tecentriq) | Genentech | PDL1-directed mAb | Urothelial carcinoma | 05/18/2016 | N/A |
Durvalumab (Imfinzi) | AstraZeneca | PDL1-directed mAb | Urothelial carcinoma | 05/01/2017 | N/A |
Enfortumab vedotin (Padcev) | Astellas | Nectin-4-directed ADC | Urothelial carcinoma | 12/18/2019 | P |
Valrubicin (Valstar) | Endo Pharm | A semisynthetic analog of anthracycline doxorubicin | BCG-refractory CIS of urinary bladder cancer | 09/25/1998 | P, O |
Erdafitinib (Balversa) | Janssen | FGFR inhibitor | Bladder cancer | 04/12/2019 | P |
Renal cell carcinoma
Bladder cancer
FDA-approved therapeutic drugs for melanoma and other skin cancers
Melanoma
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Vemurafenib (Zelboraf) | Roche | BRAF inhibitor | BRAF-positive unresectable or metastatic melanoma | 08/17/2011 | P, O |
Dabrafenib mesylate (Tafinlar) | Novartis | Kinase inhibitor with activity against BRAFV600E/D/K, wild-type BRAF and other kinases | Unresectable or metastatic melanoma with BRAFV600E mutation | 05/29/2013 | S, O |
Encorafenib (Braftovi) | Array BioPharma | BRAF inhibitor | BRAF-mutated melanoma | 06/27/2018 | S, O |
Trametinib DMSO (Mekinist) | Novartis | MEK1/2 inhibitor | Unresectable or metastatic melanoma with BRAFV600E mutation | 05/29/2013 | S, O |
Cobimetinib fumarate (Cotellic) | Genentech | MEK inhibitor | Melanoma with BRAFV600E/K mutations | 11/10/2015 | P, O |
Binimetinib (Mektovi) | Array BioPharma | MEK inhibitor | BRAF-mutated melanoma | 06/27/2018 | S, O |
Ipilimumab (Yervoy) | Bristol-Myers Squibb | CTLA4‑directed mAb | Unresectable or metastatic melanoma | 03/25/2011 | P, O |
Pembrolizumab (Keytruda) | Merck | PD1-directed mAb | Metastatic melanoma | 09/04/2014 | P, O |
Nivolumab (Opdivo) | Bristol-Myers Squibb | PD1-directed mAb | Unresectable or metastatic melanoma | 12/22/2014 | P, O |
Vismodegib (Erivedge) | Genentech | Smoothened inhibitor | Advanced basal cell carcinoma | 01/30/2012 | P |
Sonidegib phosphate (Odomzo) | Sun Pharma | Smoothened inhibitor | Basal cell carcinoma | 07/24/2015 | S |
Avelumab (Bavencio) | Emd Serono | PDL1-directed mAb | Merkel cell carcinoma | 03/23/2017 | P, O |
Cemiplimab (Libtayo) | Regeneron | PD1-directed mAb | Cutaneous squamous cell carcinoma | 09/28/2018 | P |
Basal cell carcinoma
Merkel cell carcinoma
Cutaneous squamous cell carcinoma
FDA-approved therapeutic drugs for thyroid cancer and other solid tumors
Thyroid cancer
Kaposi’s sarcoma
Liposarcoma
Soft tissue sarcoma
Tenosynovial giant cell tumor
Epithelioid sarcoma
Glioblastoma
Neuroblastoma
Malignant pleural mesothelioma
NTRK-positive solid tumors
Drug (brand name) | Sponsor | Properties | Indication | Approval date | Review |
---|---|---|---|---|---|
Thyrotropin alfa (Thyrogen) | Genzyme | Recombinant human thyroid-stimulating hormone | Thyroid cancer | 11/30/1998 | O |
Lenvatinib mesylate (Lenvima) | Eisai | Multitarget TKI (VEGFRs, FGFRs, PDGFRα, RET, and KIT) | Thyroid cancer | 02/13/2015 | P, O |
Vandetanib (Caprelsa) | Genzyme | Multitarget TKI (VEGFR2/3, EGFR, and RET) | Unresectable or metastatic medullary thyroid cancer | 04/06/2011 | P, O |
Cabozantinib S-malate (Cometriq) | Exelixis | Multitarget TKI (VEGFRs, MET, RET, FLT3, KIT, TIE2, and AXL) | Progressive, metastatic medullary thyroid cancer | 11/29/2012 | P, O |
Alitretinoin (Panretin) | Concordia | 9-cis-retinoic acid, a form of vitamin A | AIDS-related Kaposi’s sarcoma | 02/02/1999 | P, O |
Trabectedin (Yondelis) | Janssen | Alkylating drug | Liposarcoma or leiomyosarcoma | 10/23/2015 | P, O |
Olaratumab (Lartruvo) | Eli Lilly | PDGFRα-directed mAb | Soft tissue sarcoma | 10/19/2016 | P, O |
Pexidartinib HCl (Turalio) | Daiichi Sankyo | CSF1R, KIT, and FLT3 inhibitor | Tenosynovial giant cell tumor | 08/02/2019 | P, O |
Tazemetostat (Tazverik) | Epizyme | EZH2 inhibitor | Epithelioid sarcoma | 01/23/2020 | P, O |
Temozolomide (Temodar) | Merck | DNA alkylating agent | Glioblastoma | 08/11/1999 | P, O |
Dinutuximab (Unituxin) | United Therap | GD2‑directed mAb | High-risk neuroblastoma | 03/10/2015 | P, O |
Naxitamab (Danyelza) | Y-mAbs | GD2-directed mAb | High-risk neuroblastoma | 11/25/2020 | P, O |
Pemetrexed disodium (Alimta) | Eli Lilly | Folate analog | Malignant pleural mesothelioma | 02/04/2004 | P, O |
Larotrectinib sulfate (Vitrakvi) | Bayer | TRKs inhibitor | NTRK-positive solid tumors | 11/26/2018 | P, O |