AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receive the US FDA’s Approval as First HER2-Directed Therapy for HER2-low Metastatic Breast Cancer
Shots:
- The approval was based on the P-III (DESTINY-Breast04) trial evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 557 patients with HR+ or HR-, HER2-low unresectable & metastatic breast cancer prior treated with one or two prior lines of CT at multiple sites in Asia, EU & North America
- The results showed a 50% reduction in risk of disease progression or death, m-PFS (9.9 vs 5.1mos.); m-OS (23.4mos. vs 16.8mos.) with a 36% reduction in risk of death. The safety profile was consistent with prior clinical trials with no new safety concerns, 12% had confirmed ILD or pneumonitis
- The application is being reviewed in multiple countries. Enhertu (6.4mg/kg) was approved in multiple countries for LA or metastatic HER2+ gastric or GEJ adenocarcinoma
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.
