Herceptin (trastuzumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Genentech, Inc. Herceptin (trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf. Revised October 2010. Accessed October 6, 2026.

Regulatory approvals

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

Indication	Statements
Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	HER2-positive	Adenocarcinoma of the Gastroesophageal Junction	Trastuzumab