On December 15, 2025, the FDA expanded approval for fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo, Inc.) in combination with pertuzumab (Perjeta®) as first-line treatment of people with HER2-positive advanced or metastatic breast cancer. The approval includes a companion diagnostic test for selecting potentially eligible people. This approval is based on results from the phase III DESTINY-Breast09 clinical trial.
Fam-Trastuzumab Deruxtecan-Nxki (Enhertu®) for First-Line Treatment of HER2+ MBC
- US Food and Drug Administration: FDA approves fam-trastuzumab deruxtecan-nxki (Enhertu®) with pertuzumab (Perjeta®) as first-line treatment for HER2+ MBC
Clinical Trials for Fam-Trastuzumab Deruxtecan-Nxki (Enhertu®)
- Metastatic Trial Search: Trials for fam-trastuzumab deruxtecan-nxki (Enhertu®)
Last Modified on January 7, 2026