Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to fam-trastuzumab deruxtecan-nxki for the adjuvant treatment of adult patients with HER2-positive (immunohistochemistry 3+ or in situ hybridization positive) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment.

This is written in the approval document as:

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment.

Citation

Daiichi Sankyo. Enhertu (fam-trastuzumab deruxtecan-nxki) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761139s041s043lbl.pdf. Revised May 2026. Accessed October 8, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2026-10-08	Van Allen lab	Initial curation of this indication into moalmanac-db.
2026-05-15	Food and Drug Administration	Indication received traditional approval.