Last reviewed · How we verify
Cetuximab/Erbitux
Cetuximab/Erbitux is a EGFR inhibitor (monoclonal antibody) Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Metastatic colorectal cancer (KRAS wild-type), Head and neck squamous cell carcinoma, Non-small cell lung cancer (EGFR-expressing).
Cetuximab is a monoclonal antibody that blocks the epidermal growth factor receptor (EGFR) on cancer cells, preventing tumor growth and survival signals.
Cetuximab, also known as Erbitux, is an antibody that targets and inhibits the epidermal growth factor receptor (EGFR), a protein involved in cell growth and division. It is used to treat various types of cancer, including squamous cell carcinoma of the head and neck, non-small-cell lung carcinoma, and other lung cancers.
-
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
Bristol-Myers Squibb 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 | Cetuximab/Erbitux |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | EGFR inhibitor (monoclonal antibody) |
| Target | EGFR (Epidermal Growth Factor Receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cetuximab binds to EGFR with high affinity, competitively inhibiting ligand binding and preventing receptor activation. This blocks downstream signaling pathways (MAPK and PI3K/AKT) that drive cell proliferation and survival. The antibody also recruits immune cells to mediate antibody-dependent cellular cytotoxicity (ADCC) against EGFR-expressing tumor cells.
Approved indications
- Metastatic colorectal cancer (KRAS wild-type)
- Head and neck squamous cell carcinoma
- Non-small cell lung cancer (EGFR-expressing)
Common side effects
- Acneiform rash
- Diarrhea
- Nausea
- Fatigue
- Vomiting
- Infusion reactions
- Hypomagnesemia
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:
- Cetuximab/Erbitux CI brief — competitive landscape report
- Cetuximab/Erbitux updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Cetuximab/Erbitux
What is Cetuximab/Erbitux?
How does Cetuximab/Erbitux work?
What is Cetuximab/Erbitux used for?
Who makes Cetuximab/Erbitux?
What drug class is Cetuximab/Erbitux in?
What development phase is Cetuximab/Erbitux in?
What are the side effects of Cetuximab/Erbitux?
What does Cetuximab/Erbitux target?
Related
- Drug class: All EGFR inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting EGFR (Epidermal Growth Factor Receptor)
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer (KRAS wild-type)
- Indication: Drugs for Head and neck squamous cell carcinoma
- Indication: Drugs for Non-small cell lung cancer (EGFR-expressing)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing