Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receives the MHLW’s Approval as the First HER2 Directed Therapy for HER2 Low Metastatic Breast Cancer
- 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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