Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to cetuximab for the treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal cancer, as determined by an FDA-approved test, who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

This is written in the approval document as:

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 as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

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

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.