Erbitux (cetuximab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

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 6, 2026.

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 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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	BRAF p.V600E	Colorectal Adenocarcinoma	Cetuximab, Encorafenib