Summit Therapeutics submits BLA to FDA for ivonescimab

Summit Therapeutics (SMMT) announced that it has submitted a Biologics License Application to the U.S. FDA seeking approval for ivonescimab, the novel, first-in-class investigational bispecific antibody, in combination with chemotherapy in second-line or later treatment of patients with epidermal growth factor receptor-mutated locally advanced or metastatic non-squamous non-small cell lung cancer. The BLA submission was based on the overall results of the global Phase III HARMONi trial. The BLA was submitted during the fourth quarter of 2025. Based upon standard review timelines, if the application is accepted as submitted, the company anticipates a decision from the agency by the fourth quarter of 2026.