AstraZeneca and Daiichi Sankyo’s Enhertu Receive the NMPA’s Approval as First HER2-Directed Therapy for HER2-Low Metastatic Breast Cancer
Shots:
- The NMPA has approved Enhertu as monotx. for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6mos. of completing adjuvant CT
- The NMPA was based on the P-III trial (DESTINY-Breast04) results presented at ASCO 2022 and published in the NEJM evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 557 patients at multiple sites in Asia, EU & North America
- The results showed a 50% reduction in risk of disease progression & death, m-PFS (9.9 vs 5.1mos.) in all randomized patients with HER2-low metastatic breast cancer, 36% reduction in risk of death with an m-OS (23.4 vs 16.8mos.). The safety profile was consistent with other trials with no new safety signals
Ref: AstraZeneca | Image: AstraZeneca
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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.
