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Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

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  • Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy
  • Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts
  • Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2 vs 8.1mos. while mPFS was 13.2 vs 8.3mos. in HER2 ultralow population; data was presented at ASCO 2024 & published in The NEJM

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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