DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care
Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Trastuzumab deruxtecan (Enhertu) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
First approval for Daiichi Sankyo and AstraZeneca’s ENHERTU in China
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