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 · 2024FDA Approval: Revumenib (Revuforj) for Acute LeukemiaIn November 2024 the FDA approved revumenib (Revuforj), the first menin inhibitor, for relapsed or refractory acute leukemia with a KMT2A translocation.
- Regulatory T cells and stem-cell transplantation · 2026Regulatory T Cells and Graft-versus-Host Disease: Context for a New FDA ApprovalFDA approved a donor regulatory T-cell product used with stem-cell transplantation for certain adults with blood cancers. It is not a general cancer vaccine.
- Acute myeloid leukemia treatment · 2026Oral AML Treatment for Some Older Adults: What an FDA Approval Does—and Does Not—SayA 2026 FDA approval added an oral combination for a defined group with newly diagnosed AML. The full label and patient criteria matter.
- FDA oncology approvals · 2026How to Read an FDA Cancer Approval Headline Without Overgeneralizing ItAn FDA cancer approval may apply only to a defined cancer, biomarker, stage, and treatment history. The label details matter.
- weekly-roundup · 2026What Changed This Week in FDA Cancer Approvals: July 21, 2026A plain-language weekly roundup of FDA oncology approvals and what patients should ask before assuming a headline applies to them.
- approval-literacy · 2026What Changed This Week in FDA Cancer Approvals: How to Read the PageA recurring FDA approval literacy article explaining labels, indications, accelerated approvals, biomarkers, and patient questions.
- FDA oncology approvals · 2026FDA Oncology Approval Source Table: July 21, 2026A source-table version of recent FDA oncology approval activity, with patient questions and the limits of what an approval headline can tell you.
- relapsed or refractory mantle cell lymphoma · 2026FDA Grants Accelerated Approval to Sonrotoclax for Relapsed Mantle Cell LymphomaFDA granted accelerated approval to sonrotoclax for adults with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy including a BTK inhibitor.
- muscle-invasive bladder cancer · 2026FDA Expands Pembrolizumab and Enfortumab Vedotin Around Bladder SurgeryFDA approved pembrolizumab or pembrolizumab Qlex with enfortumab vedotin before and after cystectomy for adults with muscle-invasive bladder cancer who are candidates for surgery.
- multiple myeloma · 2026FDA Approves Subcutaneous Isatuximab for Multiple Myeloma IndicationsFDA approved subcutaneous isatuximab-irfc for several multiple myeloma indications, creating an under-the-skin option for regimens already using isatuximab.
- HR-positive, HER2-negative breast cancer · 2026FDA Approves Gedatolisib for Some HR-Positive, HER2-Negative Breast CancersFDA approved gedatolisib with fulvestrant, with or without palbociclib, for certain adults with HR-positive, HER2-negative advanced breast cancer without a detected PIK3CA mutation.
- PTEN-deficient metastatic prostate cancer · 2026FDA Approves Capivasertib for PTEN-Deficient Metastatic Prostate CancerFDA approved capivasertib with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naive or sensitive prostate cancer.
- RET fusion-positive solid tumors · 2026Selpercatinib Gets Traditional FDA Approval for RET Fusion Solid TumorsThe FDA converted selpercatinib's RET fusion-positive solid tumor approval to traditional approval. Here is what tumor-agnostic approval means, who it may apply to, and why biomarker testing matters.
- FDA oncology approvals · 2026What the July 2026 FDA Cancer Approvals MeanSeveral FDA oncology actions landed in mid-July 2026. Here is what changed for breast cancer, RET fusion tumors, bladder cancer, and multiple myeloma - and what approval news does not mean for every patient.
- 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 · 2011Ruxolitinib (Jakafi) FDA Approval History: Every Indication and DateRuxolitinib (Jakafi) has four FDA indications: myelofibrosis (2011), polycythemia vera (2014), acute GVHD (2019), and chronic GVHD (2021).
- 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 CancerIn December 2022 the FDA granted accelerated approval to adagrasib (Krazati) for adults with KRAS G12C-mutated advanced non-small cell lung cancer who have had at least one prior systemic therapy. What the trial showed and what it did not.
- Leukemia · 2019FDA Approval: Acalabrutinib (Calquence) for LeukemiaIn November 2019 the FDA approved acalabrutinib (Calquence), a BTK inhibitor, for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. What the ELEVATE-TN and ASCEND trials showed, and what they did not.
- Prostate cancer · 2011FDA Approval: Abiraterone (Zytiga) for Prostate CancerIn April 2011 the FDA approved abiraterone acetate (Zytiga) with prednisone for metastatic castration-resistant prostate cancer after docetaxel chemotherapy. The trial showed people lived longer. Here is what was approved and what it means.
- Breast cancer · 2017FDA Approval: Abemaciclib (Verzenio) for Breast CancerIn September 2017 the FDA approved abemaciclib (Verzenio), a CDK4/6 inhibitor, for advanced HR-positive, HER2-negative breast cancer that had progressed on hormone therapy. What the MONARCH trials showed and what they did not.
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