Enhertu (trastuzumab deruxtecan) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Daiichi Sankyo, Inc. Enhertu (trastuzumab deruxtecan) [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 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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).	1
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
FDA (1)	HER2-positive	Invasive Breast Carcinoma	Paclitaxel, Pertuzumab, Trastuzumab, Trastuzumab deruxtecan