Merck Voluntarily Withdraws Ifinatamab Deruxtecan License Application for Small Cell Lung Cancer

04:56 PM EDT, 09/25/2026 (MT Newswires) -- Merck (MRK) said late Friday it has voluntarily withdrawn its biologics license application seeking accelerated approval in the US for Daiichi Sankyo and Merck's ifinatamab deruxtecan to treat adults with extensive-stage small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. The company said it decided to withdraw the BLA following discussions with the US Food and Drug Administration, which indicated that the data supporting the application, including from the IDeate-Lung01 Phase 2 trial, do not satisfy the requirements for an accelerated approval for the proposed indication.