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

Merck and Daiichi Sankyo have voluntarily withdrawn their Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) aimed at treating extensive-stage small cell lung cancer in the U.S. This decision follows discussions with the FDA, indicating that the data from the IDeate-Lung01 phase 2 trial did not meet the necessary requirements for accelerated approval. The accelerated approval pathway is designed for serious conditions with unmet medical needs.