Last reviewed 2026-04-20 · How we verify

CETUXIMAB

At a glance

Approved indications

• Locally or regionally advanced SCCHN
• Recurrent locoregional or metastatic SCCHN
• Recurrent or metastatic SCCHN after platinum-based therapy
• K-Ras wild-type, EGFR-expressing mCRC with FOLFIRI
• K-Ras wild-type, EGFR-expressing mCRC with irinotecan
• K-Ras wild-type, EGFR-expressing mCRC as single-agent
• BRAF V600E mutation-positive mCRC

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

• Cutaneous adverse reactions (rash, pruritus, nail changes)
• Headache
• Diarrhea
• Infection
• Fatigue
• Nausea
• Dermatitis acneiform
• Abdominal pain
• Decreased appetite
• Arthralgia
• Rash
• Pruritus

Serious adverse events

• Infusion reaction (allergic reaction/anaphylactoid reaction)
• Late radiation toxicities - salivary glands
• Late radiation toxicities - larynx
• Late radiation toxicities - subcutaneous tissue
• Late radiation toxicities - mucous membrane
• Late radiation toxicities - esophagus
• Late radiation toxicities - skin

Key clinical trials

• 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)
• A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. (PHASE1)
• Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment (PHASE3)
• Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer (PHASE1)
• Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma (PHASE2)
• Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System (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:

• CETUXIMAB CI brief — competitive landscape report
• CETUXIMAB updates RSS · CI watch RSS