Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies
Shots:
- 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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
