Datroway approved in the EU for first-line metastatic TNBC patients unsuitable for immunotherapy

CAR-T Digest - August 2020

31 July 2026: Datroway approved in the EU for first-line metastatic TNBC patients unsuitable for immunotherapy

Daiichi Sankyo and AstraZeneca announced that Datroway has been approved in the EU 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, making it the only TROP2-directed medicine approved in the EU with an overall survival benefit in this setting
The approval is based on the Phase 3 TROPION-Breast02 trial, where Datroway improved median overall survival by 5.0 months versus chemotherapy (23.7 vs. 18.7 months; OS HR=0.79) and reduced the risk of disease progression or death by 43% (PFS HR=0.57), with median PFS of 10.8 vs. 5.6 months and ORR of 62.5% vs. 29.3%
The approval addresses a major unmet need in metastatic TNBC, with approximately 70% of patients not candidates for immunotherapy and historically limited to chemotherapy in the first-line setting
Datroway is a TROP2-directed ADC comprising a humanized anti-TROP2 IgG1 antibody linked to multiple topoisomerase I inhibitor DXd payloads through tetrapeptide-based cleavable linkers, enabling targeted delivery of cytotoxic payloads to TROP2-expressing tumor cells
Strategically, the EU approval strengthens Datroway’s position in the first-line TNBC landscape, with its demonstrated survival benefit supporting differentiation from other TROP2-directed therapies and expanding Daiichi Sankyo and AstraZeneca’s growing ADC franchise in breast cancer