FDA Accepts SMMT's Application Seeking Approval for NSCLC Drug

Key Takeaways SMMT's FDA-accepted BLA seeks approval of ivonescimab plus chemo for NSCLC after third-generation EGFR-TKIs.SMMT faces Nov. 14, 2026, PDUFA date, with FDA planning mid- and late-cycle reviews and labeling talks.SMMT's BLA is backed by the phase III HARMONi data that met PFS, while OS missed but trended favorably.Summit Therapeutics (SMMT) announced that the FDA has accepted its biologics license application (BLA) seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, ...