Daiichi Sankyo and Merck Withdraw I-DXd Approval Application in Small Cell Lung Cancer

Daiichi Sankyo and Merck have withdrawn their application for accelerated approval of ifinatamab deruxtecan (I-DXd) in small cell lung cancer. The decision followed discussions with the FDA, which concluded that the IDeate-Lung01 dataset did not meet the requirements needed for accelerated approval.

The phase 2 IDeate-Lung01 trial enrolled 187 patients across Asia, Europe, and North America who had received at least one prior line of platinum-based chemotherapy. The primary endpoint was objective response rate by blinded independent central review.

The companies stated that they are continuing to evaluate the role of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer and other types of difficult-to-treat cancer.