DATROWAY approved in China for patients with previously treated metastatic HR Positive, HER2 negative breast cancer

CAR-T Digest - August 2020

25 August 2025: DATROWAY approved in China for patients with previously treated metastatic HR Positive, HER2 negative breast cancer

DATROWAY (Datopotamab deruxtecan) has been approved in China for patients with previously treated metastatic HR-positive, HER2-negative breast cancer, marking its first approval in the country
The approval is based on TROPION-Breast01 Phase 3 trial, where DATROWAY reduced the risk of disease progression or death by 37% versus chemotherapy, with median PFS of 6.9 vs 4.9 months and ORR of 36% vs 23%
In the China subgroup, DATROWAY showed stronger benefits with median PFS of 8.1 vs 4.2 months and ORR of 38.6% vs 17.9% compared to chemotherapy
This is the second DXd-based ADC approved in China from Daiichi Sankyo after ENHERTU, reinforcing the company’s ADC portfolio alongside AstraZeneca
While overall survival did not reach statistical significance, the approval provides patients with a new TROP2-targeted ADC option after progression on endocrine therapy and chemotherapy, addressing a major unmet need