Datroway approved in China for metastatic TNBC ineligible for PD-1/PD-L1 inhibitors

CAR-T Digest - August 2020

08 October 2026: Datroway approved in China for metastatic TNBC ineligible for PD-1/PD-L1 inhibitors

Daiichi Sankyo and AstraZeneca announced that Datroway has been approved in China for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, marking its second breast cancer indication in China
The approval is based on the Phase 3 TROPION-Breast02 trial, where Datroway reduced the risk of disease progression or death by 43% versus chemotherapy (HR=0.57), with median progression-free survival of 10.8 versus 5.6 months; median overall survival improved by five months to 23.7 versus 18.7 months (HR=0.79)
The approval addresses a major unmet need in metastatic TNBC, particularly for patients ineligible for immunotherapy, who represent approximately 70% of metastatic cases and have historically relied on chemotherapy, with limited treatment options and poor prognosis
Datroway is a TROP2-directed ADC comprising a humanized anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor DXd payload through a cleavable linker, enabling targeted cytotoxic delivery to TROP2-expressing tumor cells
Strategically, the approval establishes Datroway as the first TROP2-directed ADC approved in China for this patient population with demonstrated OS benefit, strengthening Daiichi Sankyo and AstraZeneca’s breast cancer franchise and expanding Datroway’s role in first-line metastatic TNBC