Merck and Daiichi Sankyo Withdraw BLA for Ifinatamab Deruxtecan

Merck and Daiichi Sankyo have voluntarily withdrawn their Biologics License Application (BLA) for ifinatamab deruxtecan, a treatment for adult patients with extensive-stage small cell lung cancer. The decision to withdraw the application comes after discussions with the FDA, which determined that the data supporting the application did not satisfy requirements needed to support an accelerated approval.

The BLA was seeking accelerated approval in the U.S. based on results from the IDeate-Lung01 Phase 2 trial. However, patient enrollment continues in the IDeate-Lung02 Phase 3 trial, which is evaluating the efficacy and safety of ifinatamab deruxtecan compared to treatment of physician's choice of chemotherapy.

Merck and Daiichi Sankyo stated that they are continuing to evaluate the role of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer and other difficult-to-treat cancers. The companies expressed gratitude to the patients, their families, and investigators who have participated in these studies.