Weekly Digest - January 2025

Weekly Digest - January 2025

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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