Datroway recommended for approval in the EU as 1st-line treatment for patients with metastatic TNBC who are not candidates for immunotherapy

CAR-T Digest - August 2020

Weekly Digest - July 2026

26 June 2026: Datroway recommended for approval in the EU as 1st-line treatment for patients with metastatic TNBC who are not candidates for immunotherapy

AstraZeneca and Daiichi Sankyo’s Datroway has been recommended for approval by the EMA’s CHMP as a first-line monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, moving the therapy one step closer to approval in the European Union
The recommendation was supported by results from the phase 3 TROPION-Breast02 trial, where Datroway showed a median overall survival 23.7 months (HR=0.79), reduced the risk of disease progression or death by 43% (PFS HR=0.57), and achieved a higher objective response rate of 62.5%, demonstrating clinically meaningful superiority over standard chemotherapy
If approved by the European Commission, Datroway would provide the first targeted first-line treatment alternative to chemotherapy for approximately 70% of metastatic TNBC patients who are not eligible for immunotherapy, addressing a major unmet need in one of the most aggressive breast cancer subtypes
Datroway is a TROP2-directed DXd antibody-drug conjugate that combines a humanized anti-TROP2 antibody with a cleavable linker and a potent topoisomerase I inhibitor payload, enabling targeted delivery of cytotoxic therapy while producing a bystander killing effect in heterogeneous tumors
Strategically, the positive CHMP opinion further strengthens AstraZeneca and Daiichi Sankyo’s leadership in TROP2-targeted oncology, reinforces the growing role of ADCs in replacing conventional chemotherapy in breast cancer, and marks another significant step toward establishing Datroway as a global standard of care in first-line metastatic TNBC