FDA Approves ENHERTU® for HER2-Low Breast Cancer, Showing 36% Risk Reduction and Hazard Ratio of 0.64

Jan 28, 2025, 12:04 AM

The U.S. Food and Drug Administration (FDA) has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki) as the first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer. This approval is specifically for patients who have experienced disease progression following one or more endocrine therapies. Clinical data indicates that ENHERTU® demonstrated a 36% reduction in the risk of disease progression or death compared to chemotherapy, with a hazard ratio of 0.64 (95% confidence interval: 0.54-0.76; p<0.0001) in a trial involving chemotherapy-naïve patients with HER2-low or HER2-ultralow metastatic breast cancer. The approval marks a significant advancement in treatment options for this patient population, which previously had limited therapeutic alternatives.