Drug approvals & regulation

What cancer drug approvals actually mean for eligible patients — evidence, risks, and limits.

Every page here follows one idea: what happened, why it matters, and what it does not mean. Educational only — not medical advice.

• Leukemia · 2016FDA Approval: Venetoclax (Venclexta) for LeukemiaFDA approved Venetoclax (Venclexta), a BCL-2 inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Melanoma · 2011FDA Approval: Vemurafenib (Zelboraf) for MelanomaFDA approved Vemurafenib (Zelboraf), a BRAF inhibitor, for certain people with melanoma. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2020FDA Approval: Tucatinib (Tukysa) for Breast cancerFDA approved Tucatinib (Tukysa), a HER2 tyrosine kinase inhibitor, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 1998FDA Approval: Trastuzumab (Herceptin) for Breast cancerFDA approved Trastuzumab (Herceptin), a HER2-targeted antibody, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2019FDA Approval: Trastuzumab deruxtecan (Enhertu) for Breast cancerFDA approved Trastuzumab deruxtecan (Enhertu), an antibody-drug conjugate, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2017FDA Approval: Tisagenlecleucel (Kymriah) for LeukemiaFDA approved Tisagenlecleucel (Kymriah), a CD19 CAR T-cell therapy, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Multiple myeloma · 2022FDA Approval: Teclistamab (Tecvayli) for Multiple myelomaFDA approved Teclistamab (Tecvayli), a BCMA/CD3 bispecific, for certain people with multiple myeloma. What was approved, the evidence, and what it does and doesn't mean.
• Melanoma · 2015FDA Approval: Talimogene laherparepvec (Imlygic) for MelanomaFDA approved Talimogene laherparepvec (Imlygic), an oncolytic virus, for certain people with melanoma. What was approved, the evidence, and what it does and doesn't mean.
• Kidney cancer · 2006FDA Approval: Sunitinib (Sutent) for Kidney cancerFDA approved Sunitinib (Sutent), a multikinase inhibitor, for certain people with kidney cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2021FDA Approval: Sotorasib (Lumakras) for Lung cancerFDA approved Sotorasib (Lumakras), a KRAS G12C inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Liver cancer · 2007FDA Approval: Sorafenib (Nexavar) for Liver cancerFDA approved Sorafenib (Nexavar), a multikinase inhibitor, for certain people with liver cancer. What was approved, the evidence, and what it does and doesn't mean.
• Prostate cancer · 2010FDA Approval: Sipuleucel-T (Provenge) for Prostate cancerFDA approved Sipuleucel-T (Provenge), a therapeutic cancer vaccine, for certain people with prostate cancer. What was approved, the evidence, and what it does and doesn't mean.
• Childhood cancer · 2020FDA Approval: Selumetinib (Koselugo) for Childhood cancerFDA approved Selumetinib (Koselugo), a MEK inhibitor for neurofibromatosis, for certain people with childhood cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2020FDA Approval: Selpercatinib (Retevmo) for Lung cancerFDA approved Selpercatinib (Retevmo), a RET inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2020FDA Approval: Sacituzumab govitecan (Trodelvy) for Breast cancerFDA approved Sacituzumab govitecan (Trodelvy), an antibody-drug conjugate, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2011FDA Approval: Ruxolitinib (Jakafi) for LeukemiaFDA approved Ruxolitinib (Jakafi), a JAK1/2 inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Ovarian cancer · 2016FDA Approval: Rucaparib (Rubraca) for Ovarian cancerFDA approved Rucaparib (Rubraca), a PARP inhibitor, for certain people with ovarian cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lymphoma · 1997FDA Approval: Rituximab (Rituxan) for LymphomaFDA approved Rituximab (Rituxan), an anti-CD20 antibody, for certain people with lymphoma. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2017FDA Approval: Ribociclib (Kisqali) for Breast cancerFDA approved Ribociclib (Kisqali), a CDK4/6 inhibitor, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Colorectal cancer · 2012FDA Approval: Regorafenib (Stivarga) for Colorectal cancerFDA approved Regorafenib (Stivarga), a multikinase inhibitor, for certain people with colorectal cancer. What was approved, the evidence, and what it does and doesn't mean.
• Stomach cancer · 2014FDA Approval: Ramucirumab (Cyramza) for Stomach cancerFDA approved Ramucirumab (Cyramza), an anti-VEGFR2 antibody, for certain people with stomach cancer. What was approved, the evidence, and what it does and doesn't mean.
• Prostate cancer · 2013FDA Approval: Radium-223 (Xofigo) for Prostate cancerFDA approved Radium-223 (Xofigo), a targeted alpha therapy, for certain people with prostate cancer. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2012FDA Approval: Pertuzumab (Perjeta) for Breast cancerFDA approved Pertuzumab (Perjeta), a HER2-targeted antibody, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Cancer · 2017FDA Approval: Pembrolizumab — tissue-agnostic (MSI-H) for CancerFDA approved Pembrolizumab — tissue-agnostic (MSI-H), an anti-PD-1 checkpoint inhibitor, for certain cancers with specific biomarkers. What was approved, the evidence, and what it does and doesn't mean.
• Melanoma · 2014FDA Approval: Pembrolizumab (Keytruda) for MelanomaFDA approved Pembrolizumab (Keytruda), an anti-PD-1 checkpoint inhibitor, for certain people with melanoma. What was approved, the evidence, and what it does and doesn't mean.
• Colorectal cancer · 2006FDA Approval: Panitumumab (Vectibix) for Colorectal cancerFDA approved Panitumumab (Vectibix), an anti-EGFR antibody, for certain people with colorectal cancer. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2015FDA Approval: Palbociclib (Ibrance) for Breast cancerFDA approved Palbociclib (Ibrance), a CDK4/6 inhibitor, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2015FDA Approval: Osimertinib (Tagrisso) for Lung cancerFDA approved Osimertinib (Tagrisso), an EGFR inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Ovarian cancer · 2014FDA Approval: Olaparib (Lynparza) for Ovarian cancerFDA approved Olaparib (Lynparza), a PARP inhibitor, for certain people with ovarian cancer. What was approved, the evidence, and what it does and doesn't mean.
• Melanoma · 2014FDA Approval: Nivolumab (Opdivo) for MelanomaFDA approved Nivolumab (Opdivo), an anti-PD-1 checkpoint inhibitor, for certain people with melanoma. What was approved, the evidence, and what it does and doesn't mean.
• Ovarian cancer · 2017FDA Approval: Niraparib (Zejula) for Ovarian cancerFDA approved Niraparib (Zejula), a PARP inhibitor, for certain people with ovarian cancer. What was approved, the evidence, and what it does and doesn't mean.
• Colorectal cancer · 2014FDA Approval: Multi-target stool DNA test (Cologuard) for Colorectal cancerFDA approved Multi-target stool DNA test (Cologuard), a noninvasive screening test, for certain people with colorectal cancer. What was approved, the evidence, and what it does and doesn't mean.
• Prostate cancer · 2022FDA Approval: Lutetium-177 vipivotide tetraxetan (Pluvicto) for Prostate cancerFDA approved Lutetium-177 vipivotide tetraxetan (Pluvicto), a radioligand therapy, for certain people with prostate cancer. What was approved, the evidence, and what it does and doesn't mean.
• Thyroid cancer · 2015FDA Approval: Lenvatinib (Lenvima) for Thyroid cancerFDA approved Lenvatinib (Lenvima), a multikinase inhibitor, for certain people with thyroid cancer. What was approved, the evidence, and what it does and doesn't mean.
• Multiple myeloma · 2006FDA Approval: Lenalidomide (Revlimid) for Multiple myelomaFDA approved Lenalidomide (Revlimid), an immunomodulatory drug, for certain people with multiple myeloma. What was approved, the evidence, and what it does and doesn't mean.
• Cancer · 2018FDA Approval: Larotrectinib (Vitrakvi) for CancerFDA approved Larotrectinib (Vitrakvi), a NTRK inhibitor, for certain cancers with specific biomarkers. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2018FDA Approval: Ivosidenib (Tibsovo) for LeukemiaFDA approved Ivosidenib (Tibsovo), an IDH1 inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Melanoma · 2011FDA Approval: Ipilimumab (Yervoy) for MelanomaFDA approved Ipilimumab (Yervoy), an anti-CTLA-4 checkpoint inhibitor, for certain people with melanoma. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2001FDA Approval: Imatinib (Gleevec) for LeukemiaFDA approved Imatinib (Gleevec), a BCR-ABL tyrosine kinase inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2013FDA Approval: Ibrutinib (Imbruvica) for LeukemiaFDA approved Ibrutinib (Imbruvica), a BTK inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Cervical cancer · 2006FDA Approval: Human papillomavirus vaccine (Gardasil) for Cervical cancerFDA approved Human papillomavirus vaccine (Gardasil), a preventive vaccine, for certain people with cervical cancer. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2000FDA Approval: Gemtuzumab ozogamicin (Mylotarg) for LeukemiaFDA approved Gemtuzumab ozogamicin (Mylotarg), an antibody-drug conjugate, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2004FDA Approval: Erlotinib (Tarceva) for Lung cancerFDA approved Erlotinib (Tarceva), an EGFR inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Prostate cancer · 2012FDA Approval: Enzalutamide (Xtandi) for Prostate cancerFDA approved Enzalutamide (Xtandi), an androgen receptor inhibitor, for certain people with prostate cancer. What was approved, the evidence, and what it does and doesn't mean.
• Cancer · 2019FDA Approval: Entrectinib (Rozlytrek) for CancerFDA approved Entrectinib (Rozlytrek), a ROS1/NTRK inhibitor, for certain cancers with specific biomarkers. What was approved, the evidence, and what it does and doesn't mean.
• Bladder cancer · 2019FDA Approval: Enfortumab vedotin (Padcev) for Bladder cancerFDA approved Enfortumab vedotin (Padcev), an antibody-drug conjugate, for certain people with bladder cancer. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2017FDA Approval: Enasidenib (Idhifa) for LeukemiaFDA approved Enasidenib (Idhifa), an IDH2 inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2018FDA Approval: Durvalumab (Imfinzi) for Lung cancerFDA approved Durvalumab (Imfinzi), an anti-PD-L1 checkpoint inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Uterine cancer · 2021FDA Approval: Dostarlimab (Jemperli) for Uterine cancerFDA approved Dostarlimab (Jemperli), an anti-PD-1 checkpoint inhibitor, for certain people with uterine cancer. What was approved, the evidence, and what it does and doesn't mean.
• Multiple myeloma · 2015FDA Approval: Daratumumab (Darzalex) for Multiple myelomaFDA approved Daratumumab (Darzalex), an anti-CD38 antibody, for certain people with multiple myeloma. What was approved, the evidence, and what it does and doesn't mean.
• Melanoma · 2014FDA Approval: Dabrafenib + trametinib for MelanomaFDA approved Dabrafenib + trametinib, a BRAF/MEK inhibitors, for certain people with melanoma. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2011FDA Approval: Crizotinib (Xalkori) for Lung cancerFDA approved Crizotinib (Xalkori), an ALK inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Colorectal cancer · 2004FDA Approval: Cetuximab (Erbitux) for Colorectal cancerFDA approved Cetuximab (Erbitux), an anti-EGFR antibody, for certain people with colorectal cancer. What was approved, the evidence, and what it does and doesn't mean.
• Multiple myeloma · 2012FDA Approval: Carfilzomib (Kyprolis) for Multiple myelomaFDA approved Carfilzomib (Kyprolis), a proteasome inhibitor, for certain people with multiple myeloma. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2020FDA Approval: Capmatinib (Tabrecta) for Lung cancerFDA approved Capmatinib (Tabrecta), a MET inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Kidney cancer · 2016FDA Approval: Cabozantinib (Cabometyx) for Kidney cancerFDA approved Cabozantinib (Cabometyx), a multikinase inhibitor, for certain people with kidney cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lymphoma · 2011FDA Approval: Brentuximab vedotin (Adcetris) for LymphomaFDA approved Brentuximab vedotin (Adcetris), an antibody-drug conjugate, for certain people with lymphoma. What was approved, the evidence, and what it does and doesn't mean.
• Multiple myeloma · 2003FDA Approval: Bortezomib (Velcade) for Multiple myelomaFDA approved Bortezomib (Velcade), a proteasome inhibitor, for certain people with multiple myeloma. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2014FDA Approval: Blinatumomab (Blincyto) for LeukemiaFDA approved Blinatumomab (Blincyto), a CD19/CD3 bispecific, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Colorectal cancer · 2004FDA Approval: Bevacizumab (Avastin) for Colorectal cancerFDA approved Bevacizumab (Avastin), an anti-VEGF antibody, for certain people with colorectal cancer. What was approved, the evidence, and what it does and doesn't mean.
• Kidney cancer · 2021FDA Approval: Belzutifan (Welireg) for Kidney cancerFDA approved Belzutifan (Welireg), a HIF-2α inhibitor, for certain people with kidney cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lymphoma · 2017FDA Approval: Axicabtagene ciloleucel (Yescarta) for LymphomaFDA approved Axicabtagene ciloleucel (Yescarta), a CD19 CAR T-cell therapy, for certain people with lymphoma. What was approved, the evidence, and what it does and doesn't mean.
• Bladder cancer · 2016FDA Approval: Atezolizumab (Tecentriq) for Bladder cancerFDA approved Atezolizumab (Tecentriq), an anti-PD-L1 checkpoint inhibitor, for certain people with bladder cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2015FDA Approval: Alectinib (Alecensa) for Lung cancerFDA approved Alectinib (Alecensa), an ALK inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2013FDA Approval: Ado-trastuzumab emtansine (Kadcyla) for Breast cancerFDA approved Ado-trastuzumab emtansine (Kadcyla), an antibody-drug conjugate, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.
• Lung cancer · 2022FDA Approval: Adagrasib (Krazati) for Lung cancerFDA approved Adagrasib (Krazati), a KRAS G12C inhibitor, for certain people with lung cancer. What was approved, the evidence, and what it does and doesn't mean.
• Leukemia · 2017FDA Approval: Acalabrutinib (Calquence) for LeukemiaFDA approved Acalabrutinib (Calquence), a BTK inhibitor, for certain people with leukemia. What was approved, the evidence, and what it does and doesn't mean.
• Prostate cancer · 2011FDA Approval: Abiraterone (Zytiga) for Prostate cancerFDA approved Abiraterone (Zytiga), an androgen synthesis inhibitor, for certain people with prostate cancer. What was approved, the evidence, and what it does and doesn't mean.
• Breast cancer · 2017FDA Approval: Abemaciclib (Verzenio) for Breast cancerFDA approved Abemaciclib (Verzenio), a CDK4/6 inhibitor, for certain people with breast cancer. What was approved, the evidence, and what it does and doesn't mean.