AstraZeneca (AZN) Dato-DXd Breast Cancer BLA Gets FDA Acceptance

AstraZeneca (AZN) and partner Daiichi Sankyo announced that the FDA has accepted their biologics license application (BLA) seeking approval of the antibody drug conjugate, datopotamab deruxtecan (Dato-DXd), for a breast cancer indication.The BLA is seeking approval of Dato-DXd for treating unresectable or metastatic HR+ HER2- breast cancer in patients who have received prior systemic therapy for unresectable or metastatic disease.The FDA is expected to give its decision on the BLA in the first quarter of 20 ...