Biopharmaceutical oncology company Summit Therapeutics Inc (NASDAQ:SMMT) announced on Thursday that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for ivonescimab in combination with chemotherapy for patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) following tyrosine kinase inhibitor (TKI) therapy.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal action date of 14 November 2026.

Summit's BLA submission is based on results from the global Phase III HARMONi study, which compared ivonescimab plus platinum-doublet chemotherapy with placebo plus platinum-doublet chemotherapy in previously TKI-treated patients. Over 14,000 patients in the United States are eligible for treatment in this setting, highlighting the significant unmet medical need addressed by ivonescimab.

The FDA plans to conduct a complete review following Good Review Management Principles, including mid-cycle and wrap-up meetings, and will propose labelling subject to the review outcome.