Summit Therapeutics Inc. has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for ivonescimab, an investigational bispecific antibody, in combination with chemotherapy for the second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The submission is based on results from the global Phase III HARMONi trial. If accepted, a decision from the FDA is anticipated by the fourth quarter of 2026.
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: 20260112655330) on January 12, 2026, and is solely responsible for the information contained therein.
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