FDA Approves Enhertu® for HER2-Low MBC

On August 5, 2022, the FDA approved trastuzumab deruxtecan (Enhertu®) for the treatment of people with HER2-low MBC who have received chemotherapy. This new approval is based on results from the DESTINY-Breast04 phase III trial. The drug was previously approved only for people with HER2-positive MBC.

• FORCE: New FDA Approval for Targeted Treatment of HER2-Low MBC
• National Cancer Institute: Trastuzumab Deruxtecan (Enhertu®) for Metastatic HER2-Low Breast Cancer

• Category: FDA Approval, Special Topics
• Tag: Antibody Drug Conjugates, FDA Approval, HER2