FDA Accepts Summit Therapeutics’ (SMMT) BLA For Ivonescimab In NSCLC With November 14 PDUFA Date Following Positive Phase III Data

Summit Therapeutics Inc. (NASDAQ:SMMT) is one of the stocks that should double by 2030. On January 29, Summit Therapeutics announced that the US FDA accepted its BLA (Biologics License Application) for ivonescimab used in combination with chemotherapy. The treatment targets patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) who have progressed after TKI therapy. The FDA established a PDUFA goal action date of November 14 this year, for its regulatory decision.

The submission is supported by data from the Phase III HARMONi global study, which compared the ivonescimab combination against a placebo and chemotherapy regimen. Ivonescimab is a bispecific antibody designed to simultaneously block PD-1 and VEGF, potentially offering higher efficacy by targeting the tumor microenvironment more precisely than previous therapies.

A medical technician holding the instruments in her hands

This specific patient population represents a significant unmet need, with 14,000+ individuals in the US eligible for treatment annually. While currently approved in China, ivonescimab remains an investigational therapy in Summit’s licensed territories, including North America and Europe.

Summit Therapeutics Inc. (NASDAQ:SMMT) is a biopharmaceutical company that discovers, develops, and commercializes patient, physician, caregiver, and society-friendly medicinal therapies.

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Disclosure: None. This article is originally published at Insider Monkey.