Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to fam-trastuzumab deruxtecan-nxki followed by a taxane, trastuzumab, and pertuzumab for the neoadjuvant treatment of adult patients with HER2-positive (immunohistochemistry 3+ or in situ hybridization positive) Stage II or III breast cancer as determined by an FDA-authorized test. This indication is based on DESTINY-Breast11 (NCT05113251), a randomized, open-label, multicenter study in which patients received fam-trastuzumab deruxtecan-nxki for 4 cycles followed by paclitaxel concurrent with trastuzumab and pertuzumab for 4 cycles.

This is written in the approval document as:

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or Stage III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP).

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	Paclitaxel, Pertuzumab, Trastuzumab, 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.