ENHERTU® (fam-Trastuzumab Deruxtecan-nxki; T-DXd)

The FDA on May 15, 2026, approved ENHERTU® for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, Trastuzumab, and Pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with Trastuzumab (with or without Pertuzumab) and taxane-based treatment. ENHERTU®  is a product of Daiichi Sankyo, Inc.