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 (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: 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 (#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.

“DATROWAY has shown the potential to replace traditional chemotherapy and improve survival for patients with metastatic triple negative breast cancer, the most aggressive type of breast cancer with one of the worst prognoses,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “This EMA validation represents the potential for a second indication for DATROWAY in breast cancer and another step forward in the approval process in Europe.”

“Approximately seven of every ten patients with metastatic triple negative breast cancer are unable to receive immunotherapy due to the biology of their tumors or other factors. Chemotherapy remains the first-line standard of care for these patients,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “With this validation of our application for DATROWAY, based on the pivotal TROPION-Breast02 results, we have taken a meaningful step towards bringing these patients in Europe an alternative to traditional chemotherapy for the first time.”

Additional regulatory submissions for DATROWAY in this indication are underway globally.