FDA and EMA Oncology Drug Approvals in Q3 2026 Included Multiple Options for Treatment of Breast and Bladder Cancers

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 34 new or expanded indications for previously approved agents, including 7 new oncology agents in the third quarter of 2026. The approvals included approximately 20 solid tumor types and 1 hematologic malignancy. Nearly half of the approvals were for biologics or biosimilars; there were 3 biosimilar and 10 biologic approvals. There were 2 biologics approved for new bladder cancer indications by both the FDA and the EMA: enfortumab vedotin (Padcev®; Astellas Pharma) and pembrolizumab (Keytruda®; Merck).  

Additional highlights from the third quarter of 2026

• Drug approvals encompassed 25 different modes of action/targets; the most common were antibody-drug conjugates (4) and PD-1 inhibitors (3) 
• Nearly one-quarter of the approvals were treatments for breast cancer; the next most common tumor types were bladder (3 approvals) and multiple myeloma (4 approvals) 
• The FDA approved a new treatment for pancreatic cancer, daraxonrasib (Rasonque™; Revolution Medicines) approximately 6.5 months ahead of the goal date 
• Zidesamtinib (Jideytro™; Glaxo SmithKline) became GlaxoSmithKline’s first FDA-approved agent in lung cancer and received approval approximately 2 months ahead of its original target action date 
• The FDA also approved 4 companion technologies 
  • The Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer and ESR1 mutations for treatment with camizestrant (Etcamah®, AstraZeneca) or with imlunestrant (Inluriyo®, Eli Lilly and Company) and abemaciclib 
  • PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail (Ventana Medical Systems, Inc/Roche Diagnostics), for identifying patients with HER2-amplified gastric, gastroesophageal junction, and esophageal adenocarcinoma for treatment with zanidatamab-hrii (Ziihera®; Jazz Pharmaceuticals)
• Selpercatinib (Retevmo®; Eli Lilly and Company), a RET inhibitor, received conversion from accelerated to traditional approval by the FDA for treatment of solid tumors with RET gene fusion
• On July 8, 2026, the FDA issued a Safety Labeling Change notification letter for immune checkpoint inhibitors to add the risk of myocarditis-myositis-myasthenia gravis overlap syndrome to their labels
• On September 1, 2026, Bristol Myers Squib voluntarily withdrew the accelerated approval indication for adagrasib (Krazati®) in combination with cetuximab for treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy
  • Adagrasib is still FDA-approved for treatment of NSCLC under accelerated approval
• On September 30, 2026, Jazz Pharmaceuticals voluntarily withdrew the accelerated approval indication for lurbinectedin (Zepzelca®) for treatment of metastatic SCLC with disease progression on or after platinum-based chemotherapy
  • Lurbinectedin is still FDA-approved in combination with atezolizumab for extensive-stage SCLC maintenance therapy in adults without disease progression after induction with carboplatin + etoposide + atezolizumab

The tables below summarize key oncology approvals in Q3 2026. Treatments in bold font represent new agent approvals; all others are indication expansions, biosimilars, or conversion from accelerated to full approval (FDA).

FDA and EMA Approvals 

^aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information; 

^bBiologic; 

^cBiosimilar;  

^dAccelerated approval. 

ALK, anaplastic lymphoma kinase; ccRCC, clear-cell renal cell carcinoma; CDK4/6, cyclin-dependent kinases 4 and 6; CELMoD, cereblon E3 ligase modulator; EMA, European Medicines Agency; ER, estrogen receptor; ESR1, estrogen receptor 1 gene; FDA, US Food and Drug Administration; FGFR2, fibroblast growth factor receptor 2; G-CSF, granulocyte colony-stimulating factor; GEJ, gastroesophageal junction; GEP-NET, gastroenteropancreatic neuroendocrine tumor; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ISH, in situ hybridization; KRAS, Kirsten rat sarcoma viral oncogene homolog; MOA, mechanism of action; MTORC1/2, raptor-mammalian target of rapamycin complex 1/2; NSCLC, non-small cell lung cancer; PARP, poly (ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PI3K, phosphoinositide 3-kinase; RANKL, receptor activator of nuclear factor Kapp-B ligand; RAS GTPase, rat sarcoma guanosine triphosphate enzyme; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1; RTK, receptor tyrosine kinase; sBCC, superficial basal cell carcinoma; SCLC, small cell lung cancer; SERD, selective estrogen receptor degrader. 

Sources: 

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights