AstraZeneca and Daiichi Sankyo announced that Datroway (datopotamab deruxtecan) was approved by the European Commission as a first-line treatment 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 based on the Phase III TROPION-Breast02 trial, in which Datroway improved median overall survival by five months compared with chemotherapy, reaching 23.7 months versus 18.7 months, and reduced the risk of disease progression or death by 43%. The approval makes Datroway the only TROP2-directed antibody-drug conjugate approved in the EU with demonstrated overall survival benefit in the first-line metastatic TNBC setting.
