Merck and Daiichi Sankyo pull accelerated approval request for lung cancer ADC

Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan. The FDA indicated that the data package did not satisfy the requirements for accelerated approval in extensive-stage small cell lung cancer.

The ADC, also known as I-DXd, was being developed for patients whose disease progressed after platinum-based chemotherapy. The companies will continue to evaluate the drug in an ongoing Phase 3 trial, keeping the possibility of a future filing open.

Analysts at RBC Capital Markets described the move as an incremental negative setback for Merck, but suggested it could be a net positive for competitors such as GSK and Roche that are pursuing similar lung-cancer therapies.