Merck and Daiichi Sankyo withdraw US application for ifinatamab deruxtecan in small cell lung cancer

Merck and Daiichi Sankyo voluntarily withdrew the US Biologics License Application for ifinatamab deruxtecan (I-DXd) in previously treated extensive-stage small cell lung cancer. The FDA said the supporting data, including the Phase 2 IDeate-Lung01 trial, did not meet the requirements for accelerated approval. The companies continue Phase 3 work, including IDeate-Lung02, which is near completing enrollment.

• Accelerated-approval BLA voluntarily withdrawn
• FDA view: IDeate-Lung01 data do not meet accelerated approval requirements
• IDeate-Lung02 Phase 3 enrollment near completion; IDeate-Prostate01 and IDeate-Esophageal01 ongoing