The FDA approved datopotamab deruxtecan (Dato-DXd; Datroway) for unresectable or metastatic triple-negative breast cancer patients who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on phase 3 TROPION-Breast02 results showing overall survival benefit over investigator’s choice of chemotherapy. In the trial, median OS was 23.7 months with Dato-DXd versus 18.7 months with chemotherapy (HR 0.79; P=.0290). The update also reported a 43% reduction in risk of progression or death (HR 0.57) and higher objective response rate (64% versus 30%). For oncology development, the label supports an expanded first-line TROP2-directed ADC option in a biologically and clinically challenging subset of TNBC.