The FDA approved datopotamab deruxtecan-dlnk (Datroway; Dato-DXd) as a first-line treatment option for unresectable or metastatic triple-negative breast cancer (TNBC) in adults who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on the phase 3 TROPION-Breast02 trial (NCT05374512), which compared Dato-DXd against investigator’s-choice chemotherapy. Datopotamab deruxtecan improved overall survival (median 23.7 vs 18.7 months; HR 0.79; P=.0290) and progression-free survival (median 10.8 vs 5.6 months). The FDA also highlighted response depth: the objective response rate was 64% with Dato-DXd versus 30% with chemotherapy. The regimen is designed for a subset of TNBC patients where immune checkpoint options are not appropriate. For clinicians and developers, the decision further confirms TROP2 as a viable ADC anchor in metastatic TNBC and expands the role of TROP2-directed therapies beyond later-line settings.