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New FDA Approvals
September 9, 2026
sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.)
locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations from SOHO-01.
September 4, 2026
camizestrant (Etcamah, AstraZeneca)
in combination with a CDK4/6 inhibitor for HR+, HER2- locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy from SERENA-6 trial.
August 26, 2026
daraxonrasib (RASONQUE, Revolution Medicines, Inc.)
metastatic pancreatic adenocarcinoma after at least one prior systemic therapy or not eligible for multiagent systemic therapy from RASolute 302.
August 25, 2026
zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals)
in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.) and in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for HER2+ (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma from HERIZON-GEA-01 trial.
August 13, 2026
iberdomide (Zenbexus, Bristol-Myers Squibb Company)
in combination with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma after at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent from EXCALIBER-RRMM.
August 6, 2026
vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.)
in combination with nivolumab for unresectable advanced cutaneous melanoma with disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen from IGNYTE trial.
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