AstraZeneca and Daiichi Sankyo Receive FDA Approval for Enhertu in HER2-Low Breast Cancer

AstraZeneca and Daiichi Sankyo today announced that the FDA has approved Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. In the Phase 3 DESTINY-Breast04 trial, Enhertu demonstrated a statistically significant improvement in progression-free survival and overall survival compared to chemotherapy. The median OS was 23.4 months for Enhertu versus 16.8 months for chemotherapy. This approval expands the definition of HER2-targetable breast cancer.