Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab
Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease
Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
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