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Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

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  • The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone
  • Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6% (10 CRs & 236 PRs) vs 34.4% (0 CR & 134 PRs) & mDoR of 14.3 vs 8.6mos. in overall pts (n=866)
  • Results in HER2 low pts (n=713) showed mPFS of 13.2 vs 8.1mos., cORR of 62% (9 CRs & 193 PRs) vs 35.2% (0 CR & 114 PRs) & mDoR of 14.1 vs 8.6mos. while the data in HER2 ultralow pts (n=153) depicted improved PFS aligning with HER2 low pts, mPFS of 15.1 vs 8.3mos., cORR of 65.7% vs 30.8% & mDoR of 14.3 vs 14.1mos.

Ref: Daiichi Sankyo | Image: Daiichi Sankyo & AstraZeneca

Related News:- Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

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