Merck and Daiichi Sankyo's Lung Cancer Drug Bid Fails FDA Accelerated Approval Hurdle

Daiichi Sankyo and Merck have withdrawn their application for accelerated approval of ifinatamab deruxtecan (I-DXd) in small cell lung cancer after the FDA said the data did not meet the requirements for that pathway.

The Biologics License Application was for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. An FDA decision had been expected by October 10, but the companies pulled their bid after discussions with the agency made it clear that the data from the phase 2 IDeate-Lung01 trial did not satisfy the accelerated approval requirements.

I-DXd is an investigational antibody-drug conjugate targeting B7-H3, a protein found on many cancers. The drug links an antibody to a chemotherapy payload and was discovered by Daiichi Sankyo before being jointly developed with Merck.