AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer
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- The EC has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts who have received endocrine therapy & ≥1L of CT in the advanced setting
- Approval was based on global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin, capecitabine, vinorelbine or gemcitabine) in HR+/HER2- breast cancer pts (n=732)
- Study showed improved PFS of 37% per BICR, mPFS (6.9 vs 4.9mos.), cORR (36% vs 23%), plus mDoR (6.7 vs 5.7mos); OS failed to achieve statistical significance, with mOS of 18.6 vs 18.3mos. Data was published in JCO
Ref: Daiichi Sankyo | Image: AstraZeneca & Daiichi Sankyo
Related News:- Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
