Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to trastuzumab for the treatment of patients with HER2-overexpressing breast cancer. The product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for herceptin.

This statement is based on a regulatory approval from the Food and Drug Administration:

Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2 -overexpressing breast cancer. 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. Genentech, Inc. Herceptin (trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf. Revised January 2008. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2008-01-18	Food and Drug Administration	Indication received traditional approval.