- Enhertu has received U.S. FDA approval as the first HER2-directed therapy for unresectable or metastatic hormone receptor (HR)-positive breast cancer.
- Trastuzumab deruxtecan significantly prolonged progression-free survival compared with chemotherapy in patients with HER2-low or HER2-ultralow metastatic breast cancer.
- The DESTINY-Breast06 Phase III trial, led by Dr. Bardia, demonstrated the efficacy of trastuzumab deruxtecan.
- Approximately 85% to 90% of HR-positive, HER2-negative metastatic breast cancers were identified as HER2-low or HER2-ultralow, leading to reclassification for a significant number of patients.
- The safety profile of trastuzumab deruxtecan was consistent with prior studies, with no new safety concerns reported.
- Enhertu redefines treatment paradigms for HR-positive metastatic breast cancer, introducing a targeted HER2-directed therapy for patients with limited therapeutic options after endocrine therapy.
FDA Approves Enhertu for Metastatic, HR-Positive, HER2-Low or -Ultralow Breast Cancer
Conexiant
January 28, 2025
