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Erbitux (Cetuximab)
Erbitux (Cetuximab) is a EGFR inhibitor (monoclonal antibody) Biologic drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Metastatic colorectal cancer (KRAS wild-type), Squamous cell carcinoma of the head and neck, Non-small cell lung cancer. Also known as: Erbitux.
Cetuximab is a monoclonal antibody that blocks the epidermal growth factor receptor (EGFR) on cancer cells, preventing tumor growth and survival signals.
Cetuximab is a monoclonal antibody that blocks the epidermal growth factor receptor (EGFR) on cancer cells, preventing tumor growth and survival signals. Used for Metastatic colorectal cancer (KRAS wild-type), Squamous cell carcinoma of the head and neck, Non-small cell lung cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Erbitux (Cetuximab) |
|---|---|
| Also known as | Erbitux |
| Sponsor | Eli Lilly and Company |
| Drug class | EGFR inhibitor (monoclonal antibody) |
| Target | EGFR (Epidermal Growth Factor Receptor) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cetuximab binds to EGFR on the surface of cancer cells, blocking ligand binding and preventing downstream signaling through the MAPK and PI3K/AKT pathways. This inhibition leads to reduced cell proliferation, increased apoptosis, and enhanced sensitivity to chemotherapy and radiation. It is used in cancers that express EGFR, including colorectal and head and neck malignancies.
Approved indications
- Metastatic colorectal cancer (KRAS wild-type)
- Squamous cell carcinoma of the head and neck
- Non-small cell lung cancer
Common side effects
- Acneiform rash
- Diarrhea
- Nausea
- Fatigue
- Infusion reactions
- Hypomagnesemia
- Conjunctivitis
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)
- 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)
- Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Erbitux (Cetuximab) CI brief — competitive landscape report
- Erbitux (Cetuximab) updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Erbitux (Cetuximab)
What is Erbitux (Cetuximab)?
How does Erbitux (Cetuximab) work?
What is Erbitux (Cetuximab) used for?
Who makes Erbitux (Cetuximab)?
Is Erbitux (Cetuximab) also known as anything else?
What drug class is Erbitux (Cetuximab) in?
What development phase is Erbitux (Cetuximab) in?
What are the side effects of Erbitux (Cetuximab)?
What does Erbitux (Cetuximab) target?
Related
- Drug class: All EGFR inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting EGFR (Epidermal Growth Factor Receptor)
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer (KRAS wild-type)
- Indication: Drugs for Squamous cell carcinoma of the head and neck
- Indication: Drugs for Non-small cell lung cancer
- Also known as: Erbitux
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing