Merck and Daiichi Sankyo Withdraw Lung Cancer Drug Application After FDA Discussions

Merck and Daiichi Sankyo have withdrawn their Biologics License Application for ifinatamab deruxtecan in adult patients with extensive-stage small cell lung cancer. The companies made this decision after discussions with the FDA, which indicated that the data from the IDeate-Lung01 Phase 2 trial did not meet the requirements for accelerated approval.

The withdrawal affects the proposed indication of ifinatamab deruxtecan in adult patients with ES-SCLC who have progressed on or after platinum-based chemotherapy. Patient enrollment continues in the IDeate-Lung02 Phase 3 trial, which is evaluating ifinatamab deruxtecan against physician's choice of chemotherapy in patients with relapsed ES-SCLC.

Marjorie Green, MD, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, stated that while the current dataset did not support an approval, the companies are continuing to evaluate the role of ifinatamab deruxtecan in patients with ES-SCLC and other types of cancer.