Cetuximab

The epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) is a transmembrane glycoprotein that is a member of a subfamily of type I 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.

• ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.

• None. None.contraindicated

Premedicate with an H 1 receptor antagonist. ( 2.4 ) In Combination With Radiation Therapy: Initial dose: 400 mg/m 2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy. ( 2.2 ) Subsequent doses: 250 mg/m 2 administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks). ( 2.2 ) Complete ERBITUX administration 1 hour prior to radiation therapy. ( 2.2 ) As Single-Agent or in Combination With Chemotherapy: Weekly: Administer initial dose of 400 mg/m 2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m 2 infused over 60 minutes once weekly. ( 2.2 , 2.3 ) Biweekly: Administer 500 mg/m 2 as a 120-minute intravenous infusion every two weeks. ( 2.2 , 2.3 ) Complete ERBITUX administration 1 hour prior to chemotherapy. Continue treatment until disease progression or unacceptable toxicity. ( 2.2 , 2.3 ) See full prescribing information for dosage adjustments for adverse reactions. ( 2.5 ) 2.1 Patient Selection Select patients with metastatic colorectal cancer (CRC) for treatment with ERBITUX based on the presence of: Ras wild-type, EGFR-expressing CRC [see Clinical Studies ( 14.2 )], or BRAF V600E mutation-positive metastatic CRC [see Clinical Studies ( 14.3 )] Information on FDA-approved tests for the detection of K-Ras or BRAF V600E mutations in CRC in patients with metastatic CRC is available at: http://www.fda.gov/CompanionDiagnostics.

Infusion Reactions: Monitor patients following infusion. Immediately stop and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 , 5.1 ) Cardiopulmonary Arrest: Monitor serum electrolytes during and after ERBITUX. ( 5.2 , 5.6 ) Pulmonary Toxicity: Interrupt or permanently discontinue for acute onset or worsening of pulmonary symptoms. ( 2.5 , 5.3 ) Dermatologic Toxicity: Monitor for dermatologic toxicities or infectious sequelae. Limit sun exposure. ( 2.5 , 5.4 ) Hypomagnesemia and Accompanying Electrolyte Abnormalities: Monitor during treatment and for at least 8 weeks following the completion. Replete electrolytes as necessary. ( 5.6 ) Increased tumor progression, increased mortality, or lack of benefit observed in patients with Ras-mutant mCRC. ( 5.7 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Infusion Reactions ERBITUX can cause serious and fatal infusion reactions. Infusion reactions of any grade occurred in 8.4% of 1373 patients who received ERBITUX across clinical trials. Severe (Grades 3 and 4) infusion reactions occurred in 2.2% of patients [see Adverse Reactions ( 6.1 )] . Signs and symptoms included rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hypotension, shock, loss of consciousness, myocardial infarction, and/or cardiac arrest.

The following adverse reactions are discussed in greater detail in other sections of the label: Infusion reactions [see Warnings and Precautions ( 5.1 )] . Cardiopulmonary arrest [see Warnings and Precautions ( 5.2 )] . Pulmonary toxicity [see Warnings and Precautions ( 5.3 )] . Dermatologic toxicity [see Warnings and Precautions ( 5.4 )] . Hypomagnesemia and Electrolyte Abnormalities [see Warnings and Precautions ( 5.6 )] . The most common adverse reactions (incidence ≥25%) with Erbitux as a single-agent or in combination with radiotherapy or chemotherapy (FOLFIRI, Irinotecan and 5-Fluorouracil/Platinum) are: cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection. ( 6 ) The most common adverse reactions (>25%) for ERBITUX, in combination with encorafenib, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , ERBITUX can cause fetal harm when administered to a pregnant woman. There are no available data for ERBITUX exposure in pregnant women. In an animal reproduction study, intravenous administration of cetuximab once weekly to pregnant cynomolgus monkeys during the period of organogenesis resulted in an increased incidence of embryolethality and abortion. Disruption or depletion of EGFR in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development ( see Data ). Human IgG is known to cross the placental barrier; therefore, cetuximab may be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal Data Pregnant cynomolgus monkeys were administered cetuximab intravenously once weekly during the period of organogenesis (gestation day [GD] 20-48) at dose levels 0.4 to 4 times the recommended dose of ERBITUX based on body surface area (BSA).

Metabolism

ERBITUX administered as a single-agent or in combination with concomitant chemotherapy or radiation therapy exhibits nonlinear pharmacokinetics. The area under the concentration time curve (AUC) increased in a greater than dose proportional manner while clearance of cetuximab decreased from 0.08 L/h/m 2 to 0.02 L/h/m 2 as the dose increased from 20 mg/m 2 to 200 mg/m 2 and plateaued at doses >200 mg/m 2 .

• Feb 12, 2004BLABLA125084Imclone

1. 1Rash2,2567.3%
2. 2Diarrhoea2,0026.5%
3. 3Off Label Use1,8546.0%
4. 4Nausea1,6345.3%
5. 5Vomiting1,3824.5%
6. 6Dyspnoea1,3754.5%
7. 7Neutropenia1,2133.9%
8. 8Pyrexia1,1183.6%
9. 9Dehydration1,1033.6%
10. 10Infusion Related Reaction1,0983.6%
11. 11Malignant Neoplasm Progression1,0833.5%
12. 12Death1,0653.5%
13. 13Fatigue1,0623.4%
14. 14Hypotension9183.0%
15. 15Anaemia9133.0%

Recent PubMed references pinned to Cetuximab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Enhanced Efficacy of EGFR-Targeted ADCs via p38-Mediated Noncanonical Endocytosis in EGFR-Mutant Lung Cancer Cells.
  Biological & pharmaceutical bulletin · 2026 · Otsuyama K, Morita S, Sato M, et al.
  PMID 42252196DOI 10.1248/bpb.b26-00027
• EGFR S442 ectodomain mutation confers cetuximab resistance that can be overcome by ERBB2 blockade with trastuzumab-deruxtecan.
  Cancer letters · 2026 · Harmych SJ, Joshi N, Tanaka H, et al.
  PMID 42176792DOI 10.1016/j.canlet.2026.218607
• Complete response of unresectable maxillary undifferentiated pleomorphic sarcoma with Alluminox photoimmunotherapy.
  BMJ case reports · 2026 · Kanno T, Fujioka-Kobayashi M, Tatsumi H, et al.
  PMID 42156091DOI 10.1136/bcr-2025-270695
• Topography-dependent Prognostic Value of CDK5 in Cetuximab-Treated, RAS/BRAF-wild-type Metastatic Colorectal Cancer: A Retrospective Tissue-Microarray Analysis.
  Cancer control : journal of the Moffitt Cancer Center · 2026 · Wang Q, Zheng H, Zheng Z, et al.
  PMID 42139174DOI 10.1177/10732748261453119
• Contrasting temporal dynamics of fluorescence and photoacoustic signals from Cetuximab-IRDye800 conjugate in EGFR-overexpressing tumors.
  Science advances · 2026 · Saad MA, Allen D, Sweeney A, et al.
  PMID 42090518DOI 10.1126/sciadv.adv4639
• Enhanced Anti-Tumor Activity of Cetuximab-Modified Nanostructured Lipid Carriers Loaded with Para-Quinone Methide Derivative p-QM-1h.
  International journal of molecular sciences · 2026 · Lyu X, Liu M, Li H, et al.
  PMID 42074312DOI 10.3390/ijms27083674
• STK25 inhibits cancer-associated fibroblast activation to overcome cetuximab resistance in colorectal cancer.
  Clinical and translational medicine · 2026 · Hou Y, Chen J, Hao H, et al.
  PMID 42057436DOI 10.1002/ctm2.70678
• Real-World Outcomes of First-Line Cetuximab and Platinum-Based Chemotherapy in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: A Multicenter Observational Study and Literature Review.
  Current oncology (Toronto, Ont.) · 2026 · Rakušić Z, Bišof V, Vušković S, et al.
  PMID 42041702DOI 10.3390/curroncol33040183

The 10 most recently updated of 1,201 ClinicalTrials.gov registrations naming Cetuximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
  Recruiting · Phase 2 · Interventional · 130 enrolled · Merck Sharp & Dohme LLC
  NCT07252739updated 2026-06-12
• LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 46 enrolled · M.D. Anderson Cancer Center
  NCT04616183updated 2026-06-12
• A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
  Recruiting · Phase 2 · Interventional · 150 enrolled · Merck Sharp & Dohme LLC
  NCT07209111updated 2026-06-12
• Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
  Recruiting · Phase 2 · Phase 3 · Interventional · 613 enrolled · National Cancer Institute (NCI)
  NCT01810913updated 2026-06-12
• A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
  Recruiting · Phase 1 · Phase 2 · Interventional · 190 enrolled · Merck Sharp & Dohme LLC
  NCT07286149updated 2026-06-12
• Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
  Active not recruiting · Phase 2 · Interventional · 128 enrolled · M.D. Anderson Cancer Center
  NCT01154920updated 2026-06-12
• A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
  Recruiting · Phase 2 · Interventional · 180 enrolled · Verastem, Inc.
  NCT07644559updated 2026-06-12
• Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory
  Terminated · Phase 2 · Interventional · 7 enrolled · Northwestern University
  NCT05576896updated 2026-06-12
• A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
  Active not recruiting · Phase 3 · Interventional · 841 enrolled · Pfizer
  NCT04607421updated 2026-06-11
• CIML NK Cell in Head & Neck Cancer
  Completed · Phase 1 · Interventional · 11 enrolled · Dana-Farber Cancer Institute
  NCT04290546updated 2026-06-11

CPIC-curated drug–gene pairs for Cetuximab. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• EGFCPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Cetuximab work?

The epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) is a transmembrane glycoprotein that is a member of a subfamily of type I 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.

What is Cetuximab used for?

According to FDA labeling, Cetuximab carries indications including: ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cetuximab?

Cetuximab is classified as EGFR (Epidermal Growth Factor Receptor) inhibitors, Epidermal Growth Factor Receptor Antagonist, HER1 Antagonists.

What are the brand names for Cetuximab?

Cetuximab is marketed under brand names including Erbitux.

What are the contraindications for Cetuximab?

Cetuximab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.