Drug Approval | October 16, 2024
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients
Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years
Sales reflect continued strong growth in oncology and vaccines
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
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
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
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
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