DATROWAY® Type II Variation Application Validated in the EU as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who are Not Candidates for Immunotherapy

Daiichi Sankyo and AstraZeneca annunced on 18 Dec 2025 that the European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY® (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo  and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. 

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 (#ESMO25) Congress. In the trial, DATROWAY demonstrated statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as first-line treatment for patients with metastatic TNBC for whom immunotherapy was not an option.

Press release available at this link