Shots:
- China’s NMPA has approved Datroway for treating adults with HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) inoperable or recurrent breast cancer after previous CT
- Approval was based on P-III (TROPION-Breast01) study assessing Datroway (6mg/kg, IV, Q21D) vs single-agent CT in adults (n=732) with HR+/HER2- metastatic breast cancer
- Study showed improved PFS by 37% (mPFS: 6.9 vs 4.9mos.), cORR of 36% vs 23% (2 CRs & 131 PRs vs 0 CRs & 84 PRs), & mDoR of 6.7 vs 5.7mos.; OS was not statistically significant, though adjusted OS was 19.1 vs 17.5mos. In China, Datroway had mPFS of 8.1 vs 4.2mos. & ORR of 38.6% vs 17.9%; published in The JCO
Ref: Daiichi Sankyo | Image: Daiichi Sankyo| Press Release
Related News:- Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer
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