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.
He called the EMA’s validation a significant step towards providing a new treatment option for these patients.
Susan Galbraith, Executive Vice President, Oncology Hematology R&D at AstraZeneca, noted that approximately 70% of metastatic TNBC patients are unable to access immunotherapy due to the biology of their tumors, making chemotherapy the current standard of care.
The approval of DATROWAY would mark the first alternative to chemotherapy in this setting in Europe.
The EMA’s validation follows similar regulatory activities in other regions, with additional submissions for DATROWAY’s approval underway globally.
The companies expect further progress in their efforts to provide an effective and targeted treatment for patients with metastatic TNBC.