Erbitux (cetuximab) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

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

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1
ERBITUX (cetuximab) is indicated for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC) in combination with irinotecan in patients who are refractory to other irinotecan-based chemotherapy regimens.	1
ERBITUX (cetuximab) is indicated as a single agent in patients who are intolerant to irinotecan-based chemotherapy for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC).	1
ERBITUX (cetuximab) is indicated as a single agent for the treatment of EGFR-expressing K-Ras wild-type metastatic colorectal carcinoma (mCRC) in patients who have failed both irinotecan- and oxaliplatin-based regimens and who have received a fluoropyrimidine.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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