Daiichi Sankyo and AstraZeneca Receive Health Canada’s Approval of Enhertu (trastuzumab deruxtecan) for HER2-Low Metastatic Breast Cancer
Shots:
- Enhertu received approval from Health Canada for HER2-low (IHC 1+ or IHC 2+/ISH-) metastatic or unresectable breast cancer who have received one prior line of CT in a metastatic setting or developed disease recurrence during or within 6mos. of completing adjuvant CT
- The approval was based on the P-III trial (DESTINY-Breast04) evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 557 patients at multiple sites in Asia, EU & North America
- In HER2-low metastatic breast cancer with HR+ disease & overall population, 49% & 50% reduction in risk of disease progression or death, m-PFS (10.1 vs 5.4mos. & 9.9 vs 5.1mos.), m-OS (23.9 vs 17.5mos. & 23.4 vs 16.8mos.), 36% reduction in risk of death in both groups & safety profile was consistent with prior trials with no new safety concerns
Ref: Nesswire | Image: Daiichi Sankyo
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
