The European Medicines Agency (EMA) has officially validated the marketing authorization application for DATROWAY® (datopotamab deruxtecan), a novel antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitors.
This validation begins the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
DATROWAY, jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:AZN), is specifically designed to target TROP2, a protein implicated in several aggressive cancers, including TNBC.
The application is based on the pivotal TROPION-Breast02 Phase 3 trial, which demonstrated that DATROWAY significantly improved overall survival (OS) and progression-free survival (PFS) compared to standard chemotherapy in patients with metastatic TNBC who could not receive immunotherapy.
The trial’s results were presented as a late-breaking proffered paper at the 2025 European Society for Medical Oncology (ESMO) Congress.
Ken Takeshita, M.D., Global Head of R&D at Daiichi Sankyo, emphasized that DATROWAY has the potential to replace traditional chemotherapy in treating metastatic TNBC, one of the most aggressive and hard-to-treat forms of breast cancer.