Regulatory approval

Published by the Health Canada.

Health Canada approved cetuximab 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.

This is written in the approval document as:

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.

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