DATROWAY® approved in Japan as the first TROP-2 directed therapy for patients with previously treated unresectable or recurrent HR positive, HER2 negative breast cancer

CAR-T Digest - August 2020

Weekly Digest - December 2024

27 Dec 2024: DATROWAY® approved in Japan as the first TROP-2 directed therapy for patients with previously treated unresectable or recurrent HR positive, HER2 negative breast cancer

Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan) has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with HR-positive, HER2-negative unresectable or recurrent breast cancer after chemotherapy
The approval is based on the TROPION-Breast01 phase 3 trial, where DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a mPFS of 6.9 months
In the trial, 93.6% of patients experienced adverse reactions, with nausea, stomatitis, and alopecia being the most common. Interstitial lung disease (ILD) occurred in 6.5% of Japanese patients, leading to a warning for ILD in the drug’s approval
Regulatory submissions for DATROWAY are under review in the EU, U.S., China, and other regions, as Daiichi Sankyo aims to expand its innovative cancer treatments internationally