Daiichi Sankyo and Merck Withdraw Lung Cancer Drug Application Citing Insufficient Data

Daiichi Sankyo and Merck have withdrawn their application for accelerated approval of ifinatamab deruxtecan in the US to treat extensive-stage small cell lung cancer.

The decision follows discussions with the FDA indicating that data from the IDeate-Lung01 Phase 2 trial and other supporting information do not meet requirements for accelerated approval.

Patient enrollment continues in the IDeate-Lung02 Phase 3 trial, which evaluates ifinatamab deruxtecan versus chemotherapy options in patients with relapsed extensive-stage small cell lung cancer following disease progression with one prior line of platinum-based chemotherapy.

The companies are conducting two additional Phase 3 trials with ifinatamab deruxtecan in advanced or metastatic disease, including IDeate-Prostate01 for castration-resistant prostate cancer and IDeate-Esophageal01 for esophageal squamous cell carcinoma.