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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	EGFR positive, Wild type KRAS	Colorectal Adenocarcinoma	Cetuximab, Fluorouracil, Irinotecan