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

AstraZeneca and Daiichi Sankyo today announced that the FDA has approved Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. In the Phase 3 DESTINY-Breast03 trial, Enhertu demonstrated a statistically significant improvement in progression-free survival compared to ado-trastuzumab emtansine (T-DM1). The median PFS was 28.8 months for Enhertu versus 6.8 months for T-DM1. This approval establishes Enhertu as the preferred second-line treatment for HER2-positive metastatic breast cancer.