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
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.
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
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
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
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