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Cetuximab is a chimeric antibody that blocks the EGFR growth receptor. It is used with FOLFIRI or FOLFOX in RAS wild-type, left-sided bowel cancer, with encorafenib in BRAF V600E disease, with KRAS G12C inhibitors, and with radiation or chemotherapy in head and neck cancer; RAS-mutant tumours gain nothing and may be harmed, so RAS testing comes first.
Chimeric IgG1 anti-EGFR. First-line with FOLFIRI/FOLFOX in RAS/BRAF wild-type, left-sided mCRC; with encorafenib (± chemotherapy) in BRAF V600E; with KRAS G12C inhibitors (adagrasib); in head and neck cancer with radiation or chemotherapy. Requires RAS testing (KRAS and NRAS exons 2-4) because RAS-mutant tumours do not benefit and may be harmed. Acneiform rash correlates with response; infusion reactions and hypomagnesaemia are characteristic. Biosimilars are emerging.
Backbone ribbon from PDB 1YY9. RCSB PDB 1YY9. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Binds EGFR domain III, blocking ligand binding and dimerisation; also ADCC via IgG1 Fc. Connects to EGFR.
1.Cetuximab binds the extracellular domain of EGFR on the tumour cell
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf. Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9055.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. RAS wild-type documentation required for colorectal use.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA439 · SMC advice: cetuximab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Initial approval in EGFR-expressing mCRC (BOND trial)
As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy
Confirmed: the accelerated approval of 2004 converted to traditional approval 3.6 years after it was granted.
In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy
Confirmed: the accelerated approval of 2004 converted to traditional approval 8.4 years after it was granted.
Label restricted to KRAS wild-type; first-line FOLFIRI indication (CRYSTAL)
With encorafenib for BRAF V600E mCRC (BEACON)
| Region | Year | Indication |
|---|---|---|
| US | 2004 | EGFR-expressing metastatic colorectal cancer (later restricted to RAS wild-type) |
| US | 2006 | Head and neck squamous cell carcinoma with radiation |
| US | 2020 | BRAF V600E mCRC with encorafenib |
| US | 2024 | KRAS G12C mCRC with adagrasib |
| EU | 2004 | EGFR-expressing metastatic colorectal cancer; later restricted to RAS wild-type · Erbitux marketing authorisation issued 29 June 2004. |
| England (NICE) | 2017 | Previously untreated EGFR-expressing RAS wild-type metastatic colorectal cancer with FOLFOX or FOLFIRI · TA439, published 29 March 2017 and last updated 25 September 2017, recommends cetuximab within its marketing authorisation subject to the commercial access agreement. TA242 (2012) covers use after first-line chemotherapy and NICE does not recommend cetuximab beyond first line. |
| Adverse event |
|---|
| Acneiform rash Very common; severity correlates with response |
| Hypomagnesaemia Common, can be severe; monitor electrolytes |
| Infusion reactions Including rare severe reactions; higher in the southeastern US (alpha-gal sensitisation) |
| Diarrhoea Additive with FOLFIRI |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Adagrasib plus cetuximab is an approved option for previously treated KRAS G12C colorectal cancer, alongside sotorasib plus panitumumab; monotherapy is not enough because EGFR signalling reactivates the pathway.
TPEx is a less toxic, more convenient chemotherapy backbone for patients who need cetuximab-based first-line therapy, for instance when immunotherapy is unsuitable.
Cetuximab is not an acceptable substitute for cisplatin in HPV-positive disease; de-escalation must be tested through other routes such as dose reduction after response or surgery-based pathways.
Encorafenib with cetuximab became the standard second-line treatment for BRAF V600E disease, and the platform BREAKWATER later moved into first line with chemotherapy added, doubling survival again.
It is the strongest evidence that the consensus subtypes could choose between the two first-line biologicals, and the clearest statement of why they have not: it is a retrospective analysis of a subset of one trial, on an assay nobody has validated for clinical use.
Cisplatin chemoradiation is the standard for HPV-positive oropharyngeal cancer; cetuximab is reserved for patients who cannot receive cisplatin.
The negative counterweight to FIRE-3. The two trials are reconciled only by primary tumour side, which is why the sidedness analysis rather than either trial is what guidelines now cite.
It showed the sidedness effect is not an artefact of pooling and survives adjustment for BRAF, which is what made guideline committees act on it.
Query for this drug: (TITLE:"Cetuximab" OR ABSTRACT:"Cetuximab" OR TITLE:"Erbitux" OR ABSTRACT:"Erbitux") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cetuximab, not a curated reading list.
Shares HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer, Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy, A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer, Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC.
Shares A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer, Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial, Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC, Anti-EGFR rechallenge.
Shares Combination Therapy for BRAF-V600E Metastatic CRCm, Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer, Ryan B. Corcoran, A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic.
Shares Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC, Anti-EGFR rechallenge, Prognostic and predictive relevance of primary tumor location in patients with RAS wild-type metastatic colorectal cancer: retrospective analyses of the CRYSTAL and FIRE-3 trials, CALGB/SWOG 80405.
Shares A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer, A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors, The Phase 1b/IIa, Open-label, Dose Escalation and Dose Expansion to Evaluate Safety, Tolerability, and Preliminary Efficacy of the Combination of HCB101, Cetuxi, Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC.
Shares Ryan B. Corcoran, NCIC CO.17, MRC COIN, K-ras mutations and benefit from cetuximab in advanced colorectal cancer.
Shares Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors, SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC, Combination Therapy for BRAF-V600E Metastatic CRCm, Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab.
Shares A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors, A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors, Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66), A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer.