Regulatory approval

Published by the Food and Drug Administration.

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.

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