Oncology News Central (ONC)Enhertu Approved in the EU as the First HER2-Directed Therapy for Patients with HER2-Low Metastatic Breast Cancer

The approval is based on the findings of the DESTINY-Breast04 Phase III trial and follows the Committee for Medicinal Products for Human Use’s favorable recommendation. In the trial, Enhertu (trastuzumab deruxtecan) significantly decreased the risk of disease progression or death in patients with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease by 50% compared to the physician’s choice of chemotherapy. According to a blinded independent central evaluation, Enhertu had a median progression-free survival (PFS) of 9.9 months compared to chemotherapy patients’ PFS of 5.1 months (BICR). When compared to chemotherapy, Enhertu showed a 36% reduction in the risk of death, with a median overall survival (OS) of 23.4 months as opposed to 16.8 months.