The FDA approved AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody-drug conjugate Datroway (datopotamab deruxtecan-dlnk) as a first-line option for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is anchored in the phase 3 TROPION-Breast02 trial (NCT05374512), where Datroway improved overall survival versus investigator’s choice chemotherapy (HR 0.79; median 23.7 vs 18.7 months; P=.0290).