Merck, Daiichi Sankyo Voluntarily Withdraw Biologics License Application Approval In U.S. For Ifinatamab Deruxtecan To Treat Small Cell Lung Cancer After Discussions With FDA

The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy has been voluntarily withdrawn.

The decision to withdraw the BLA is based on discussions with the U.S. Food and Drug Administration (FDA) that data supporting the application, including from the IDeate-Lung01 phase 2 trial, do not satisfy requirements needed to support an accelerated approval for the proposed indication. The accelerated approval pathway in the U.S. allows for earlier approval of medicines based on surrogate endpoints to treat serious conditions where there is an unmet medical need.