AstraZeneca, Daiichi Sankyo datopotamab deruxtecan BLA accepted in the U.S.

AstraZeneca and Daiichi Sankyo’s Biologics License Application, or BLA, for datopotamab deruxtecan, or Dato-DXd, has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is during the first quarter of 2025.