Posted by Michael Wonder on 18 Dec 2025
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
18 December 2025 - Based on TROPION-Breast02 Phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway is the first and only medicine to significantly improve overall survival versus chemotherapy in this patient population.
The EMA has validated the type II variation marketing authorisation application for Datroway (datopotamab deruxtecan) 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.
