Regulatory approval

Published by the Food and Drug Administration. Approved

ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment.

This is written in the approval document.

Citation

ImClone LLC. Erbitux (cetuximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf. Revised September 2021. Accessed October 30, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	EGFR positive, Wild type KRAS	Colorectal Adenocarcinoma	Cetuximab, Fluorouracil, Irinotecan

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2012-07-06	Food and Drug Administration	Indication received traditional approval.