Erbitux (cetuximab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1
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 irinotecan in patients who are refractory to irinotecan-based chemotherapy.	1
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.	1
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR positive, Wild type KRAS	Colorectal Adenocarcinoma	Cetuximab, Fluorouracil, Irinotecan
Sensitivity (+)	EGFR positive, Wild type KRAS	Colorectal Adenocarcinoma	Cetuximab, Irinotecan
Sensitivity (+)	EGFR positive, Wild type KRAS	Colorectal Adenocarcinoma	Cetuximab
Sensitivity (+)	BRAF p.V600E	Colorectal Adenocarcinoma	Cetuximab, Encorafenib