Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receives the MHLW’s Approval as the First HER2 Directed Therapy for HER2 Low Metastatic Breast Cancer
Shots:
- The MHLW has approved Enhertu (HER2 directed ADC) for HER2 low (IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer. 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
- The results showed a 50% reduction in risk of disease progression or death, m-PFS (9.9 vs 5.1mos.) and a 36% reduction in risk of death & the safety profile was consistent with prior trials with no new safety concerns & AEs (96.2%). The results were presented at ASCO 2022 & published in the NEJM
- Enhertu (6.4mg/kg) was approved in 30+ countries for LA or metastatic HER2+ gastric or GEJ adenocarcinoma, based on (DESTINY-Gastric01 & 02) trials results
Ref: enhertu | Image: enhertu
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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.
