Datroway Receives EU Approval for First-Line Metastatic TNBC Patients Ineligible for Immunotherapy
AstraZeneca and Daiichi Sankyo have secured European Commission approval for Datroway (datopotamab deruxtecan) as a monotherapy for the first-line treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy.
The authorization follows a favorable recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and is supported by findings from the Phase III TROPION-Breast02 study. The trial results were unveiled at the 2025 European Society for...