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 unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or