Cetuximab
An antibody that blocks the EGFR growth receptor. It works in bowel cancers with a normal RAS gene, especially left-sided ones, and is a key partner in the BRAF combination.
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.
1.Cetuximab binds the extracellular domain of EGFR on the tumour cell
- Route
- Intravenous
- Schedule
- 400 mg/m² loading then 250 mg/m² weekly, or 500 mg/m² every 2 weeks
- Dose modifications
- Hold or reduce for grade 3 rash; premedicate for infusion reactions
- Monitoring
- Magnesium, potassium, calcium; skin
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Lilly Cares Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- With chemotherapy for untreated RAS wild-type metastatic colorectal cancer
- Notes
- Head and neck squamous cell carcinoma with radiotherapy: TA145 (2008). Earlier mCRC appraisal TA176 (2009).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA439 · SMC advice: cetuximab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- Feb 2004ApprovalUS
Initial approval in EGFR-expressing mCRC (BOND trial)
- Jul 2012Label changeUS
Label restricted to KRAS wild-type; first-line FOLFIRI indication (CRYSTAL)
- Apr 2020ApprovalUS
With encorafenib for BRAF V600E mCRC (BEACON)
Approvals
| 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 |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductFOLFIRI (5-FU, leucovorin, irinotecan)
Shares Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC, CRYSTAL & FIRE-3, BREAKWATER, Colorectal cancer.
- ProductPanitumumab
Shares Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC, Receptor tyrosine kinase activation, RAS / RAF / MEK / ERK (MAPK), Monoclonal antibodies.
- ProductEncorafenib
Shares Ryan B. Corcoran, Josep Tabernero, BREAKWATER, RAS / RAF / MEK / ERK (MAPK).
- TermSidedness (left vs right colon)
Shares Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC, CRYSTAL & FIRE-3, EGFR, Colorectal cancer.
- TrialPARADIGM
Shares Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC, EGFR, Colorectal cancer.
- TermEGFR C797S
Shares Resistance routes: how a blocked pathway comes back, Receptor tyrosine kinase activation, EGFR.
- Key paperBREAKWATER: encorafenib plus cetuximab with chemotherapy as first treatment for BRAF V600E-mutated colorectal cancer
Shares Josep Tabernero, Monoclonal antibodies, EGFR, Colorectal cancer.
- Key paperKEYNOTE-048: pembrolizumab, alone or with chemotherapy, as first treatment for recurrent or metastatic head and neck cancer
Shares Merck & Co. (MSD), Monoclonal antibodies, EGFR, Head and neck squamous cell carcinoma.