Merck, Daiichi Sankyo announces BLA for I-DXd granted priority review by FDA

Daiichi Sankyo and Merck’s (MRK), known as MSD outside of the United States and Canada, Biologics License Application, BLA, for ifinatamab deruxtecan, I-DXd, has been accepted and granted Priority Review by the U.S. Food and Drug Administration, FDA, for the treatment of adult patients with extensive-stage small cell lung cancer, ES-SCLC, with disease progression on or after platinum-based chemotherapy. The Prescription Drug User Fee Act, PDUFA, date, the FDA action date for its regulatory decision, is October 10, 2026.