Enhertu approved in the US as first tumour-agnostic HER2-directed therapy
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
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
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients
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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