Posted by Michael Wonder on 15 Dec 2025
FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
15 December 2025 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.
Efficacy was evaluated in DESTINY-Breast09, a randomised, three-arm, multi-centre, global trial that enrolled 1157 adults with HER2-positive advanced or metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neo-adjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease.
