New approval brings Enhertu to earlier HR-positive treatment setting

28 January 2025

AstraZeneca (LSE: AZN) and Daiichi Sankyo’s (TYO: 4568) Enhertu (trastuzumab deruxtecan) has been approved in the USA as the first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies.

The approval brings the specifically engineered HER2-directed DXd antibody drug conjugate (ADC) to an earlier HR-positive treatment setting and broadens the patient population eligible for treatment with a HER2-directed therapy to those with HER2-ultralow disease.

This approval was based on the DESTINY-Breast06 Phase III trial results, which showed that Enhertu demonstrated superiority versus chemotherapy, with a median progression-free survival of more than one year.

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