Posted by Michael Wonder on 28 Jun 2026
Datroway recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy
26 June 2026 - AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been recommended for approval in the European Union 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.
The CHMP of the EMA based its positive opinion on results from the TROPION-Breast02 Phase 3 trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology.
