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News|Articles|September 30, 2026
FDA Oncology Recap: Approvals, Designations, and Decisions in September 2026
Author(s)Targeted Oncology Staff
Fact checked by: Sabrina Serani
September brought accelerated approvals in ESR1-mutant breast cancer and HER2-mutant non–small cell lung cancer, a Galleri panel vote, and a withdrawn I-DXd application.
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The FDA's September 2026 oncology activity included accelerated approvals for camizestrant (Etcamah) in ESR1-mutant breast cancer and sevabertinib (Hyrnuo) in treatment-naive HER2-mutant non–small cell lung cancer (NSCLC), new approvals in cholangiocarcinoma, renal cell carcinoma (RCC), and neuroendocrine tumors, and the withdrawal of an application for ifinatamab deruxtecan (I-DXd) in small cell lung cancer.¹
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