Datroway receives positive CHMP opinion for first-line TNBC in EU
- The CHMP recommended approval of Datroway (datopotamab deruxtecan) as monotherapy for first-line treatment of unresectable or metastatic triple-negative breast cancer in patients not candidates for PD-1/PD-L1 inhibitors.
- In the TROPION-Breast02 trial, Datroway significantly improved overall survival and progression-free survival versus chemotherapy.
- If approved by the European Commission, Datroway would be the first TROP2-directed ADC approved in this first-line setting in the EU.
Daiichi Sankyo and AstraZeneca (NYSE:AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization 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.
Datroway is a TROP2-directed DXd antibody-drug conjugate jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The positive opinion is based on results from the Phase 3 TROPION-Breast02 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus investigator’s choice of chemotherapy.
In the trial, Datroway reduced the risk of death by 21% (HR=0.79) with median overall survival of 23.7 months versus 18.7 months for chemotherapy, and reduced the risk of disease progression or death by 43% (HR=0.57) with median PFS of 10.8 months versus 5.6 months.
If approved by the European Commission, Datroway would become the first TROP2-directed ADC approved in the EU for this first-line setting.
The decision would apply to all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
Datroway was approved in the United States in May 2026 for the same indication, with additional regulatory reviews ongoing in several other countries.
