Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)
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- Health Canada has approved Enhertu monotx. for adult with inoperable HR+, HER2-low/ultralow MBC who have received ≥1 endocrine therapy (ET) & are ineligible for ET as the next line of therapy
- Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT (capecitabine/paclitaxel/nab-paclitaxel) in HR+, HER2-low (n=713) & ultralow (n=152) pts
- Trial showed improved PFS by 36% (mPFS: 13.2 vs 8.1mos.) & cORR of 57.3% vs 31.2%, with mDoR of 14.3 vs 8.6mos. in overall population of CT-naïve HER2-low/ultralow pts; data was presented at ASCO’24 & published in The NEJM
Ref: Daiichi Sankyo | Image: Daiichi Sankyo| Press Release
Related News:- Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer
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