Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized cetuximab as a single agent for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

This is written in the approval document as:

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

Citation

Merck Europe B.V. Erbitux (cetuximab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf. Revised May 2022. Accessed March 12, 2024.

Therapeutic response

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

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	EGFR positive, Wild type HRAS, Wild type KRAS, Wild type NRAS	Colorectal Adenocarcinoma	Cetuximab