Regulatory approval

Published by the Health Canada.

Health Canada approved cetuximab 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 as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR positive, Wild type KRAS	Colorectal Adenocarcinoma	Cetuximab, Fluorouracil, Irinotecan