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

CAR-T Digest - August 2020

Weekly Digest - December 2025

18 December 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

The European Medicines Agency has validated a Type II Variation application for DATROWAY (Datopotamab deruxtecan) as monotherapy for the first-line treatment of adults with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, formally initiating the EMA’s scientific review process
The application is supported by data from the Phase 3 TROPION-Breast02 trial, presented as a late-breaking proffered paper at ESMO 2025, where DATROWAY demonstrated statistically significant and clinically meaningful improvements in both overall survival and progression-free survival versus investigator’s choice of chemotherapy
The validation confirms the completeness of the submission and marks an important regulatory milestone, advancing DATROWAY closer to potential approval in Europe for a high-unmet-need patient population
This is particularly impactful given that approximately 70% of patients with metastatic triple negative breast cancer are not eligible for immunotherapy and continue to rely on chemotherapy as the first-line standard of care despite limited survival benefits
If approved, DATROWAY could become a new first-line standard of care for these patients in Europe, with additional regulatory submissions for this indication already underway across global markets