FDA accepts Dato-DXd BLA for breast cancer
2 April 2024 Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer Application based on results from the TROPION-Breast01 Phase III trial Additional BLA under review in the US for AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan for patients with advanced nonsquamous non-small cell lung cancer AstraZeneca and Daiichi Sankyo's Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with