Posted by Michael Wonder on 15 May 2026
FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
15 May 2026 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo) for two separate indications in adults with HER2 positive early stage breast cancer.
The first indication is for the neo-adjuvant treatment of adults with HER2 positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA authorised test, followed by taxane, trastuzumab, and pertuzumab. The second indication is for the treatment of adults with HER2 positive (IHC3+ or ISH+) breast cancer who have residual invasive disease after neo-adjuvant HER2-targeted treatment.
FDA also approved two companion diagnostic devices, the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail, both for identifying HER2-positive (IHC3+ or ISH+) patients for treatment with trastuzumab deruxtecan, consistent with the approved drug labelling.
