In December 2019, the US Food and Drug Administration (FDA) originally approved trastuzumab deruxtecan (Enhertu®), an antibody drug conjugate (ADC), for people with metastatic HER2-positive breast cancer who had received at least 2 lines of anti-HER2 targeted therapy. Approval was expanded in May 2022 for people with metastatic HER2-positive breast cancer who had received at least 1 line of anti-HER2 targeted therapy.
Then, in August 2022, approval for this drug was granted for people with HER2-low MBC who had received prior chemotherapy. This approval meant that some people who were considered triple-negative were eligible for this anti-HER2 drug.
Most recently in January 2025, the FDA approved trastuzumab deruxtecan (Enhertu®) for people with hormone receptor-positive (HR+), HER2-low or HER2-ultralow MBC who had received at least 1 line of hormone therapy. The FDA also approved a companion diagnostic test to determine who is eligible.
These approvals from the FDA mean that more patients with MBC can receive trastuzumab deruxtecan (Enhertu®)
About the Recent Approval of Trastuzumab Deruxtecan (Enhertu®)
MBC Clinical Trials
- Metastatic Trial Search: Trials for Trastuzumab Deruxtecan (Enhertu®)
Last Modified on March 3, 2025