17 Jan 2025: Datroway (Datopotamab deruxtecan) approved in the US for patients with previously treated metastatic HR+, HER2- Breast Cancer
Datroway is approved by FDA for metastatic HR-positive, HER2-negative breast cancer after prior endocrine and chemotherapy based on TROPION-Breast01 Phase 3 results
AstraZeneca highlights Datroway’s approval as the 8th of 20 new medicines planned by 2030
TROPION-Breast01 results shows Datroway reduced the risk of disease progression or death by 37% compared to chemotherapy (HR 0.63, p<0.0001)
mPFS was 6.9 months with vs. 4.9 months with chemotherapy
It showed no new safety concerns, with an interstitial lung disease rate of 4.2%, mostly low-grade events
Datroway is discovered by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo
Additional submissions for breast cancer under review in the EU, China, and other regions
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