Enhertu approved in the EU as first HER2-directed therapy for patients with HR-positive, HER2-low or HER2-ultralow metastatic Breast cancer following at least one endocrine therapy

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04 Apr 2025: Enhertu approved in the EU as first HER2-directed therapy for patients with HR-positive, HER2-low or HER2-ultralow metastatic Breast cancer following at least one endocrine therapy

The European Union has approved Enhertu (Trastuzumab deruxtecan) as the first HER2-directed therapy for adults with unresectable or metastatic HR-positive, HER2-low or HER2-ultralow Breast cancer who have received at least one endocrine therapy and are not suitable for further endocrine treatment
The approval is based on the DESTINY-Breast06 Phase 3 trial, which showed that Enhertu significantly improved progression-free survival (PFS) to over one year compared to chemotherapy, with a 38% reduction in the risk of disease progression or death
This approval expands Enhertu’s use to earlier treatment settings for HR-positive, HER2-low metastatic breast cancer and includes patients with HER2-ultralow disease, broadening the eligible patient population
Enhertu, already approved in over 75 countries for specific metastatic breast cancer indications, triggered a $125 million milestone payment from AstraZeneca to Daiichi Sankyo following this EU approval