Enhertu approved in EU for HER2-low metastatic breast cancer treatment
The European Commission has approved Enhertu (trastuzumab deruxtecan) as the first HER2-directed therapy for adult patients with HER2-low metastatic breast cancer.
AstraZeneca and Daiichi Sankyo's Enhertu has received European Union approval as a monotherapy for adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy. This marks the first HER2-directed therapy approved for this patient population.
The approval is based on results from the DESTINY-Breast04 Phase III trial. The study demonstrated that Enhertu significantly reduced the risk of disease progression or death by 50% compared to physician's choice of chemotherapy. Median progression-free survival was 9.9 months for Enhertu versus 5.1 months for chemotherapy.
Furthermore, Enhertu improved overall survival by more than six months compared to chemotherapy, with a median overall survival of 23.4 months. This expanded indication provides a new treatment option for patients whose tumors express low levels of HER2.
Previously, HER2-low breast cancer was often classified as HER2-negative, leaving patients with limited therapeutic choices beyond chemotherapy. This approval is expected to change treatment paradigms and improve outcomes for this patient group.