Merck and Daiichi withdraw FDA accelerated approval filing for B7-H3 ADC in small cell lung cancer

Merck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients.

The ADC, which targets the B7-H3 protein, was being pursued under an accelerated pathway based on early data, but the companies decided to pull the submission before the agency’s review.

The withdrawal represents another setback for the collaboration, which has faced earlier challenges, and delays any potential market entry of the therapy in the U.S.

No details were provided on whether the companies will resubmit the application after additional data or modify the development plan.