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/2025/761139s032s035lbl.pdf. Revised January 2025. 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, as monotherapy, for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ER positive, HER2-low	Invasive Breast Carcinoma	Trastuzumab deruxtecan
FDA (1)	HER2-low, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
FDA (1)	ER positive, HER2-low, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
FDA (1)	ER positive, HER2-ultralow	Invasive Breast Carcinoma	Trastuzumab deruxtecan
FDA (1)	HER2-ultralow, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
FDA (1)	ER positive, HER2-ultralow, PR positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan