AZ, Daiichi Sankyo file Dato-DXd for second indication

AstraZeneca and Daiichi Sankyo have moved swiftly to file for FDA approval of a second indication for their TROP2-directed antibody-drug conjugate datopotamab deruxtecan (Dato-DXd), this time for breast cancer.

The second biologics license application (BLA) is for the treatment of adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy, with a decision expected in the first quarter of 2025.