Summit Therapeutics BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA; PDUFA Nov 14, 2026

Summit Therapeutics Inc.

FDA accepted BLA for ivonescimab + chemotherapy in EGFR-mutated non-squamous NSCLC post-TKI therapy.
PDUFA goal action date set for November 14, 2026.
BLA submission based on Phase III HARMONi trial results.
Over 14,000 U.S. patients eligible for treatment annually in this setting.
FDA plans full review including mid-cycle and wrap-up meetings before PDUFA date.

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