Daiichi Sankyo Co. Ltd. and AstraZeneca have announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for DATROWAY® (datopotamab deruxtecan-dlnk). The review is for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The application is supported by results from the TROPION-Breast02 phase 3 trial, which demonstrated significant improvements in overall survival and reduction in the risk of disease progression or death compared to chemotherapy. The FDA’s action date for its regulatory decision is set for June 2, 2026.

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