By Fineline Cube 
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that DATROWAY has been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. This approval applies to patients who have received prior endocrine therapy and at least one line of chemotherapy in the advanced setting.
DATROWAY Mechanism and Approval
DATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. The approval by China’s National Medical Products Administration (NMPA) is based on results from the TROPION-Breast01 phase 3 trial.
Clinical Trial Results
In the TROPION-Breast01 trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy. It also prolonged the median progression-free survival (mPFS: 6.9 months vs. 4.9 months) and improved the objective response rate (ORR: 36% vs. 23%). Benefits for Chinese patients were consistent with the overall study population, and DATROWAY demonstrated a favorable safety profile.-Fineline Info & Tech