Merck, Daiichi Sankyo abandon accelerated FDA bid for B7-H3 lung cancer ADC
Merck and Daiichi Sankyo have withdrawn an FDA accelerated approval submission for a B7-H3 antibody-drug conjugate intended for certain small cell lung cancer patients. The move marks another setback for the companies' partnership.
Merck and Daiichi Sankyo have withdrawn an FDA accelerated approval submission for a B7-H3 antibody-drug conjugate intended for certain small cell lung cancer patients. The submission had sought an accelerated pathway, and its withdrawal means that specific bid is no longer active. The companies' partnership has now encountered another setback. The news sits within the broader field of oncology drug development, where experimental treatments can face changing regulatory and clinical prospects.
For patients with certain small cell lung cancer, the withdrawal may mean one less experimental option moving through an accelerated FDA pathway, though it does not remove an approved therapy. Clinicians and researchers tracking B7-H3 antibody-drug conjugates could