Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer
Shots:
- The US FDA has granted BTD to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer
- Designation was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157)
- Trial showed improved PFS by 44% (mPFS: 40.7 vs 26.9mos.) & consistent PFS benefit across subgroups, plus cORR was 85.1% vs 78.6% (58 CRs & 268 PRs vs 33 CRs & 271 PRs), mDoR exceeded 3yrs. vs 26.4mos., & interim OS showed a favorable trend. Investigator-assessed PFS depicted mPFS of 40.7 vs 20.7mos.; data was presented at ASCO 2025
Ref: Businesswire| Image: Daiichi Sankyo| Press Release
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