Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR positive and Wild type KRAS status confers therapeutic sensitivity to Cetuximab, Fluorouracil, Irinotecan in patients with Colorectal Adenocarcinoma.

The U.S. Food and Drug Administration granted approval to cetuximab in combination with FOLFIRI for the first-line treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal cancer as determined by an FDA-approved test.

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

ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment.

Citation

ImClone LLC. Erbitux (cetuximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf. Revised September 2021. Accessed October 30, 2024. ImClone LLC. Erbitux (cetuximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf. Revised July 2012. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2012-07-06	Food and Drug Administration	Indication received traditional approval.