Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2L+ Treatment of Patients with EGFRm NSCLC
Core Viewpoint - Summit Therapeutics Inc. has submitted a Biologics License Application (BLA) to the U.S. FDA for ivonescimab, a first-in-class investigational bispecific antibody, aimed at treating patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer in combination with chemotherapy [1]. Group 1 - The BLA submission is a significant step for the company as it seeks regulatory approval for ivonescimab [1]. - Ivonescimab is positioned as a novel treatment option in the second-line or later treatment setting for specific lung cancer patients [1].