Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer
Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer
Shots:
- The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with unresectable/m-HER2+ BC prior treated with trastuzumab emtansine
- Results: @median follow up of 20.5mos., ORR (61.4%); CRR (54.9%); mDoR (20.8mos.). The safety of therapy has been evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2+ BC prior treated with at least one dose of Enhertu (5.4 mg/kg) in clinical studies
- Enhertu is a HER2 directed ADC and has received EMA’s CHMP accelerated assessment in Mar’20 for the same indication
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