{"entity":{"id":"cetuximab","kind":"drug","name":"Cetuximab","aka":[],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Cetuximab","links":[{"label":"FDA label","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf"},{"label":"NICE TA439: cetuximab and panitumumab for previously untreated metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta439"},{"label":"EMA Erbitux","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux"}],"tags":[],"related":["ras-wild-type","kras-g12d"],"cancers":["colorectal","head-and-neck","recurrent-metastatic-hnscc","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr"],"drugs":[],"companies":["eli-lilly","merck"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":["crystal-fire3","breakwater","nct07775287","nct07702032","nct04793958","nct06445062","nct07059221","nct07790510","nct06194656","nct07659795","nct06943820","nct03785249","nct05194995","nct07474727","nct07644559","nct07020221","nct07259590","nct05910827","nct05217446","nct05358249","nct07223047","nct04956640","nct07415031","nct07252739","nct04585035","nct07286149","nct02671435","nct06662786","nct05584670","nct06385678","nct06750094","nct07209111","nct06915142","nct05410145","mountaineer","nct05239741","nct00248287","nct05226871","nct06332092","prime","opus","calgb-80405","swog-s1406","new-epoc","n0147","petacc-8"],"people":[],"bottlenecks":[],"keyPapers":["paper-karapetis-kras-cetuximab-colorectal-nejm-2008","paper-arnold-primary-tumour-side-ras-wild-type-ann-oncol-2017","paper-tejpar-tumour-location-crystal-fire3-jama-oncol-2017"],"journals":[],"dependsOn":[],"notes":["Colorectal cancer biomarkers: eligibility is extended RAS wild-type (KRAS and NRAS exons 2, 3 and 4) plus, in practice, a left-sided primary. RAS mutation predicts no benefit at all, with overall survival hazard ratios of 0.55 in wild-type and 0.98 in mutant tumours against supportive care (Karapetis 2008), and side is predictive as well as prognostic: overall survival hazard ratio 0.75 on the left and 1.12 on the right (Arnold 2017, Tejpar 2017). Acquired resistance appears as RAS-mutant clones in plasma months before progression (Misale 2012, Diaz 2012)."],"brand":"Erbitux","modality":"Monoclonal antibody (anti-EGFR)","mechanism":"Binds EGFR domain III, blocking ligand binding and dimerisation; also ADCC via IgG1 Fc.","approvals":[{"region":"US","year":2004,"indication":"EGFR-expressing metastatic colorectal cancer (later restricted to RAS wild-type)"},{"region":"US","year":2006,"indication":"Head and neck squamous cell carcinoma with radiation"},{"region":"US","year":2020,"indication":"BRAF V600E mCRC with encorafenib"},{"region":"US","year":2024,"indication":"KRAS G12C mCRC with adagrasib"},{"region":"EU","year":2004,"indication":"EGFR-expressing metastatic colorectal cancer; later restricted to RAS wild-type","note":"Erbitux marketing authorisation issued 29 June 2004."},{"region":"England (NICE)","year":2017,"indication":"Previously untreated EGFR-expressing RAS wild-type metastatic colorectal cancer with FOLFOX or FOLFIRI","note":"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."}],"mechanismSteps":["Cetuximab binds the extracellular domain of EGFR on the tumour cell","Ligands (EGF, TGF-α) can no longer bind; the receptor cannot pair up and signal","RAS-MAPK and PI3K signalling downstream falls, slowing growth; requires RAS to be wild-type","The IgG1 tail recruits NK cells for antibody-dependent killing"],"dosing":{"route":"Intravenous","schedule":"400 mg/m² loading then 250 mg/m² weekly, or 500 mg/m² every 2 weeks","modifications":"Hold or reduce for grade 3 rash; premedicate for infusion reactions","monitoring":"Magnesium, potassium, calcium; skin","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf"},"toxicity":[{"event":"Acneiform rash","note":"Very common; severity correlates with response"},{"event":"Hypomagnesaemia","note":"Common, can be severe; monitor electrolytes"},{"event":"Infusion reactions","note":"Including rare severe reactions; higher in the southeastern US (alpha-gal sensitisation)"},{"event":"Diarrhoea","note":"Additive with FOLFIRI"}],"access":[],"regulatoryEvents":[{"date":"2004-02-12","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy"},{"date":"2004-02-12","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy"},{"date":"2004-02","type":"approval","region":"US","note":"Initial approval in EGFR-expressing mCRC (BOND trial)"},{"date":"2007-10-02","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2004 converted to traditional approval 3.6 years after it was granted.","indication":"As a single agent for EGFR-expressing metastatic colorectal carcinoma intolerant to irinotecan-based chemotherapy"},{"date":"2012-07-06","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2004 converted to traditional approval 8.4 years after it was granted.","indication":"In combination with irinotecan for EGFR-expressing metastatic colorectal carcinoma refractory to irinotecan-based chemotherapy"},{"date":"2012-07","type":"label-change","region":"US","note":"Label restricted to KRAS wild-type; first-line FOLFIRI indication (CRYSTAL)"},{"date":"2020-04","type":"approval","region":"US","note":"With encorafenib for BRAF V600E mCRC (BEACON)"}]},"route":"/drugs/cetuximab/","neighbours":{"biomarker":[{"id":"braf-v600e","kind":"biomarker","name":"BRAF V600E (and V600K)","route":"/biomarkers/braf-v600e/"},{"id":"kras-g12c","kind":"biomarker","name":"KRAS G12C","route":"/biomarkers/kras-g12c/"},{"id":"kras-g12d","kind":"biomarker","name":"KRAS G12D (and other non-G12C KRAS mutations)","route":"/biomarkers/kras-g12d/"},{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"}],"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"braf-v600e-colorectal","kind":"cancer","name":"BRAF V600E-mutant colorectal cancer","route":"/cancers/braf-v600e-colorectal/"},{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"},{"id":"early-onset-colorectal","kind":"cancer","name":"Early-onset colorectal cancer (under 50)","route":"/cancers/early-onset-colorectal/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-negative-head-and-neck-cancer","kind":"cancer","name":"HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)","route":"/cancers/hpv-negative-head-and-neck-cancer/"},{"id":"hpv-positive-oropharyngeal-cancer","kind":"cancer","name":"HPV-positive oropharyngeal cancer","route":"/cancers/hpv-positive-oropharyngeal-cancer/"},{"id":"hypopharyngeal-cancer","kind":"cancer","name":"Hypopharyngeal cancer","route":"/cancers/hypopharyngeal-cancer/"},{"id":"kras-g12c-colorectal","kind":"cancer","name":"KRAS G12C-mutant colorectal cancer","route":"/cancers/kras-g12c-colorectal/"},{"id":"laryngeal-cancer","kind":"cancer","name":"Laryngeal and hypopharyngeal cancer","route":"/cancers/laryngeal-cancer/"},{"id":"oropharyngeal-cancer","kind":"cancer","name":"Oropharyngeal cancer (tonsil and base of tongue)","route":"/cancers/oropharyngeal-cancer/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"},{"id":"colorectal-serrated-adenocarcinoma","kind":"cancer","name":"Serrated adenocarcinoma of the colon and rectum","route":"/cancers/colorectal-serrated-adenocarcinoma/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"},{"id":"radiosensitisers","kind":"technology","name":"Radiosensitisers","route":"/technologies/radiosensitisers/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"nras","kind":"target","name":"NRAS","route":"/targets/nras/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. 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