AstraZeneca, Daiichi Sankyo get EMA validation of Datroway Type II Variation MAA

The European Medicines Agency has validated the Type II Variation marketing authorization application for Datroway as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The application is based on data from the TROPION-Breast02 phase 3 trial presented in a late-breaking proffered paper session at the 2025 European Society for Medical Oncology Congress. In the trial, Datroway demonstrated statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival compared to investigator’s choice of chemotherapy as first-line treatment for patients with metastatic TNBC for whom immunotherapy was not an option.