Posted by Michael Wonder on 28 Jan 2025
Enhertu approved in the US as first HER2 directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies
27 January 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a median progression-free survival of more than one year.
Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
