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

Regulatory approval published by the Food and Drug Administration.

Citation

Daiichi Sankyo, Inc. Enhertu (trastuzumab deruxtecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s028lbl.pdf. Revised April 2024. Accessed October 30, 2024.

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-approved 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-approved 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 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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	HER2-low	Invasive Breast Carcinoma	Trastuzumab deruxtecan
Sensitivity (+)	ERBB2 oncogenic variants	Non-Small Cell Lung Cancer	Trastuzumab deruxtecan
Sensitivity (+)	HER2-positive	Adenocarcinoma of the Gastroesophageal Junction	Trastuzumab deruxtecan
Sensitivity (+)	HER2-positive	Any solid tumor	Trastuzumab deruxtecan