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.

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