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Cetuximab Injection [Erbitux]
Cetuximab Injection [Erbitux] is a EGFR inhibitor Small molecule drug developed by Shanghai Henlius Biotech. It is currently in Phase 2 development for Metastatic colorectal cancer, Head and neck squamous cell carcinoma. Also known as: Erbitux.
Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), preventing cancer cell growth and proliferation.
Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), preventing cancer cell growth and proliferation. Used for Metastatic colorectal cancer, Head and neck squamous cell carcinoma.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 Injection [Erbitux] |
|---|---|
| Also known as | Erbitux |
| Sponsor | Shanghai Henlius Biotech |
| Drug class | EGFR inhibitor |
| Target | EGFR |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
By binding to EGFR, cetuximab blocks the receptor's interaction with its ligands, which are proteins that stimulate cell growth. This blockade prevents the activation of downstream signaling pathways that promote cell proliferation and survival, ultimately leading to the inhibition of tumor growth.
Approved indications
- Metastatic colorectal cancer
- Head and neck squamous cell carcinoma
Common side effects
- Skin rash
- Fatigue
- Diarrhea
- Hypomagnesemia
- Hypokalemia
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cetuximab Injection [Erbitux] CI brief — competitive landscape report
- Cetuximab Injection [Erbitux] updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI
Frequently asked questions about Cetuximab Injection [Erbitux]
What is Cetuximab Injection [Erbitux]?
How does Cetuximab Injection [Erbitux] work?
What is Cetuximab Injection [Erbitux] used for?
Who makes Cetuximab Injection [Erbitux]?
Is Cetuximab Injection [Erbitux] also known as anything else?
What drug class is Cetuximab Injection [Erbitux] in?
What development phase is Cetuximab Injection [Erbitux] in?
What are the side effects of Cetuximab Injection [Erbitux]?
What does Cetuximab Injection [Erbitux] target?
Related
- Drug class: All EGFR inhibitor drugs
- Target: All drugs targeting EGFR
- Manufacturer: Shanghai Henlius Biotech — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Head and neck squamous cell carcinoma
- Also known as: Erbitux
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing