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

Regulatory approval published by the Food and Drug Administration.

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.

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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 the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either (i) in the metastatic setting, or (ii) in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. 1
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. 1
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. 1
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated, as a monotherapy, for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test. 1
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
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. 6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) HER2-positive Invasive Breast Carcinoma Trastuzumab deruxtecan
FDA (1) HER2-low Invasive Breast Carcinoma Trastuzumab deruxtecan
FDA (1) ERBB2 activating variants Non-Small Cell Lung Cancer Trastuzumab deruxtecan
FDA (1) HER2-positive Adenocarcinoma of the Gastroesophageal Junction Trastuzumab deruxtecan
FDA (1) HER2-positive Any solid tumor Trastuzumab deruxtecan
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
FDA (1) HER2-positive Invasive Breast Carcinoma Pertuzumab, Trastuzumab deruxtecan
FDA (1) HER2-positive Invasive Breast Carcinoma Paclitaxel, Pertuzumab, Trastuzumab, Trastuzumab deruxtecan