FDA Accepts Biologics License Application for Summit Therapeutics' Ivonescimab in EGFR-Mutated NSCLC

Reuters01-29

FDA Accepts Biologics License Application for <a href="https://laohu8.com/S/SMMT">Summit</a> <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' Ivonescimab in EGFR-Mutated NSCLC

Summit Therapeutics Inc. announced that the U.S. Food & Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ivonescimab in combination with chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) following tyrosine kinase inhibitor (TKI) therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 14, 2026. The application is based on results from the Phase III HARMONi trial, which evaluated ivonescimab plus platinum-doublet chemotherapy compared to placebo plus chemotherapy in this patient population. The FDA will conduct a complete review of the application according to its established review management principles and practices.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Summit Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260129109846) on January 29, 2026, and is solely responsible for the information contained therein.

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