Last reviewed 2026-05-19 · How we verify

Erbitux (cetuximab)

Erbitux (generic name: cetuximab) is a Epidermal Growth Factor Receptor Antagonist [EPC] Monoclonal antibody drug developed by Imclone. It is currently FDA-approved (first approved 2004) for Head and neck cancer, Malignant tumor of colon, Rectal cancer with wild-type RAS.

Erbitux works by binding to the Epidermal Growth Factor Receptor (EGFR) on cancer cells, blocking the receptor's ability to stimulate cell growth and division.

At a glance

Mechanism of action

The epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) is transmembrane glycoprotein that is member of subfamily of type receptor tyrosine kinases including EGFR, HER2, HER3, and HER4. The EGFR is constitutively expressed in many normal epithelial tissues, including the skin and hair follicle. Expression of EGFR is also detected in many human cancers including those of the head and neck, colon, and rectum.Cetuximab binds specifically to the EGFR on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. In vitro assays and in vivo animal studies have shown that binding of cetuximab to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. Signal transduction through the EGFR r

Approved indications

• Head and neck cancer
• Malignant tumor of colon
• Rectal cancer with wild-type RAS
• Squamous cell carcinoma of larynx
• Squamous cell carcinoma of mouth
• Squamous cell carcinoma of nose
• Squamous cell carcinoma of pharynx

Boxed warnings

• WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] . Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration [see Warnings and Precautions ( 5.2 , 5.6 )] . WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete boxed warning. ERBITUX can cause serious and fatal infusion reactions. ( 5.1 , 6 ) Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 ) Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration. ( 5.2 , 5.6 )

Common side effects

• General Asthenia
• Fever
• Headache
• Chills
• Infusion Reaction
• Infection
• Nausea
• Emesis
• Diarrhea
• Dyspepsia
• Weight Loss
• Dehydration

Key clinical trials

• Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (PHASE3)
• Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME) (PHASE3)
• Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) (PHASE3)
• Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer (PHASE3)
• Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx (PHASE3)
• Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery (PHASE1,PHASE2)
• A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) (PHASE1)
• Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Erbitux CI brief — competitive landscape report
• Erbitux updates RSS · CI watch RSS
• Imclone portfolio CI

Frequently asked questions about Erbitux

Related

• Drug class: All Epidermal Growth Factor Receptor Antagonist [EPC] drugs
• Target: All drugs targeting Epidermal growth factor receptor
• Manufacturer: Imclone — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Head and neck cancer
• Indication: Drugs for Malignant tumor of colon
• Indication: Drugs for Rectal cancer with wild-type RAS

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing