Regulatory approval

Published by the Health Canada. Approved

ERBITUX (cetuximab) is indicated for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC) in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment.

This is written in the approval document.

Citation

ImClone LLC. Erbitux (cetuximab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00043071.PDF. Published January 2018. Accessed June 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	EGFR positive, Wild type KRAS	Colorectal Adenocarcinoma	Cetuximab, Fluorouracil, Irinotecan

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals