AstraZeneca and Daiichi Sankyo Receive CHMP’s Positive Opinion for Datroway to Treat HR+/HER2- Breast Cancer
Shots:
- The CHMP has recommended Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts receiving endocrine-based therapy & CT. Ongoing regulatory review in China & other regions
- Opinion was supported by a 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%, mPFS (6.9 vs 4.9mos.), cORR (36% vs 23%) with CR (0.5% vs 0%) & PR (36% vs 23%), plus mDoR (6.7 vs 5.7mos). Data was published in JCO
Ref: Daiichi Sankyo | Image: Daiichi Sankyo & AstraZeneca
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