Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to trastuzumab for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab.

This is written in the approval document as:

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.

Citation

Genentech, Inc. Herceptin (trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103792s5354lbl.pdf. Revised June 2024. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	HER2-positive	Adenocarcinoma of the Gastroesophageal Junction	Trastuzumab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2010-10-20	Food and Drug Administration	Indication received traditional approval.