FDA approved Daiichi Sankyo and AstraZeneca’s TROP2-directed antibody-drug conjugate Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The agency’s decision is based on the phase 3 TROPION-Breast02 trial, which showed statistically significant overall survival improvement versus investigator’s choice chemotherapy. In TROPION-Breast02, Datroway delivered a median OS of 23.7 months versus 18.7 months with chemotherapy (HR 0.79; P=0.0290). The study also reported reduced risk of disease progression or death (HR 0.57) and higher objective response rate (64% vs 30%). This approval expands the ADC playbook for TNBC and highlights the competitive intensity around TROP2-targeted constructs as payers and oncology groups update treatment pathways.