Merck and Daiichi Sankyo Withdraw BLA for Ifinatamab Deruxtecan in ES-SCLC

The developers of ifinatamab deruxtecan (I-DXd), a treatment for extensive-stage small cell lung cancer (ES-SCLC), have voluntarily withdrawn their biologics license application (BLA) from the FDA due to insufficient data. The decision comes after discussions with the agency regarding the phase 2 IDeate-Lung01 trial, which showed promising results but not enough to support accelerated approval.

The trial's primary end point was confirmed objective response rate (ORR), which was 48.2% among evaluable patients who received I-DXd at 12 mg/kg. However, the FDA required more convincing data to grant accelerated approval for this indication.

Despite the setback, Daiichi Sankyo and Merck will continue enrolling patients in the phase 3 IDeate-Lung02 trial, which aims to assess I-DXd's efficacy compared to chemotherapy in relapsed ES-SCLC. The companies are optimistic about the potential for a future filing with the FDA based on these results.