Drug · Monoclonal Antibody

Cetuximab

CI-DRUG-00000148Explore in graph →NCIt C1723 CHEMBL1201577 CIViC Approved

Regulatory

Approvals (15)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory13 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2021-09-24 (see label)	approved	Sep 24, 2021	openfda
US FDA	—	Efficacy supplement 2021-04-06 (see label)	approved	Apr 6, 2021	openfda
US FDA	—	Efficacy supplement 2021-04-06 (see label)	approved	Apr 6, 2021	openfda
US FDA	—	Efficacy supplement 2012-07-06 (see label)	approved	Jul 6, 2012	openfda
US

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	153	91	98	766	15	CA, EU, US	Feb 12, 2004	1999-04
Malignant Lung Neoplasm	Phase3	Phase 3	18	12	5	84	0	—	—	2000-12
Malignant Pancreatic Neoplasm	Phase3	Phase 3	10	8	1	36	0	—	—	1999-10
Malignant Colon Neoplasm	Phase3	Phase 3	6	1	4	32	0

Curated evidence

Clinical evidence (403)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–50 of 403 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BRAF V600E1
Cetuximab	Colorectal Adenocarcinoma

Clinical trials

Trials with this intervention (782)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 782 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02270814	Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma(CACTUX)	active not recruiting	Phase 2	74	Washington University School of MedicineOTHER	1	Aug 28, 2026	clinicaltrials
NCT03366155	Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Epidermal growth factor receptor erbB1 inhibitor
Targets: 1 gene
UNII: PQX0D8J21J
Aliases: ABP-494, C 225, C-225, C225, Cetuxa, Cetuximab, Cetuximab biosimilar (abp-494), Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar CMAB009, Cetuximab Biosimilar KL 140, Cetuximab-cetu, Cetuximab (genetical recombination), Chimeric Anti-EGFR Monoclonal Antibody, Chimeric MoAb C225, Chimeric Monoclonal Antibody C225, CMAB-009, CMAB009, ENZ 124, ENZ124, Erbitux, ERBITUX, IMC-225, IMC-C225, MOAB C225

Data updated 27 minutes agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FE01	CETUXIMAB
DIN (Health Canada)	02271249

EGFR Overexpression + KRAS MutationEGFR KRAS2
Cetuximab	Colorectal Adenocarcinoma	Predictive	B	Supports Adverse Response	3	submitted	EID11059 The Medical Research Council (MRC) COIN trial consisted of patients with histologically confirmed adenocarcinoma of the colon or rectum, inoperable metastatic or locoregional measurable disease, and w… (full text at CIViC) PMID 21641636 · Maughan et al., 2011 · Open in CIViC	civic
Cetuximab + ChemotherapyCombination	Colorectal Adenocarcinoma	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID11062 The Medical Research Council (MRC) COIN trial consisted of patients with histologically confirmed adenocarcinoma of the colon or rectum, inoperable metastatic or locoregional measurable disease, and w… (full text at CIViC) PMID 21641636 · Maughan et al., 2011 · Open in CIViC	civic

KRAS G13D3
Cetuximab + ChemotherapyCombination	Colorectal Adenocarcinoma	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID11054 The Medical Research Council (MRC) COIN trial consisted of patients with histologically confirmed adenocarcinoma of the colon or rectum, inoperable metastatic or locoregional measurable disease, and w… (full text at CIViC) PMID 21641636 · Maughan et al., 2011 · Open in CIViC	civic
Cetuximab	Malignant Colon Neoplasm	Predictive	B	Does Not Support Sensitivity Response	4	submitted	EID6974 In a two armed Phase II study of 53 patients with molecularly selected G13D mutant, chemotherapy-refractory metastatic CRC, 25 patients were treated with cetuximab monotherapy, and 28 with cetuximab a… (full text at CIViC) PMID 27114605 · Segelov et al., 2016 · Open in CIViC	civic
〃	Malignant Colon Neoplasm	Predictive	C	Supports Resistance	—	submitted	EID3896 In a phase 3 clinical study,�BRAF wild-type stage III colon cancer patients harboring KRAS G13D mutation (n=220) and treated with cetuximab plus chemotherapy were associated with decreased disease-fre… (full text at CIViC) PMID 24687927 · Yoon et al., 2014 · Open in CIViC	civic

KRAS Wildtype3
Cetuximab + ChemotherapyCombination	Colorectal Adenocarcinoma	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID11057 The Medical Research Council (MRC) COIN trial consisted of patients with histologically confirmed adenocarcinoma of the colon or rectum, inoperable metastatic or locoregional measurable disease, and w… (full text at CIViC) PMID 21641636 · Maughan et al., 2011 · Open in CIViC	civic
Cetuximab	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID11659 In a clinical study of 49 patients, 10 patients with Non-Small Cell Lung Cancer (NSCLC) and wild-type KRAS gene were treated with Cetuximab. After 16 weeks, no clinical activity was observed. A PFS of… (full text at CIViC) PMID 33090333 · Fisher et al., 2020 · Open in CIViC	civic
〃	Malignant Breast Neoplasm	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID11655 In a clinical study of 49 patients, 10 patients with Breast Cancer (BC) and wild-type KRAS gene were treated with Cetuximab. After 16 weeks no clinical activity was observed. PFS of 6.7 weeks (95% CI,… (full text at CIViC) PMID 33090333 · Fisher et al., 2020 · Open in CIViC	civic

EGFR Amplification3
Cetuximab	Gastric Adenocarcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID6927 This retrospective analysis of a Phase 2 trial shows significant association between increased EGFR gene copy number (≥ 4.0) and overall survival (OS) in patients with gastric and oesophago-gastric ju… (full text at CIViC) PMID 22152101 · Luber et al., 2011 · Open in CIViC	civic
Afatinib + Cetuximab + ErlotinibSubstitutes	Head and Neck Squamous Cell Carcinoma	Predictive	D	Does Not Support Sensitivity Response	2	submitted	EID9674 This retrospective preclinical study assessed the efficacies of cetuximab, afatinib, and erlotinib towards head and neck squamous cell carcinoma (HNSCC) & esophageal squamous cell carcinoma (ESCC) cel… (full text at CIViC) PMID 27207775 · Nakamura et al., 2016 · Open in CIViC	civic
Cetuximab + Fluorouracil + Platinum CompoundCombination	Head and Neck Squamous Cell Carcinoma	Predictive	B	Does Not Support Sensitivity Response	4	accepted	EID691 EGFR amplification was not a predictor of response to cetuximab/5-FU/platinum in patients with recurrent or metastatic HNSSC from the EXTREME study. PMID 21048039 · Licitra et al., 2011 · Open in CIViC	civic

IDH1 R1322
Cetuximab	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	—	submitted	EID3718 In a clinical study of 63 recurrent glioma patients, de novo glioblastoma patients treated with cetuximab monotherapy (n=27) and harboring IDH1 codon 132 mutation were associated with improved overal… (full text at CIViC) PMID 22199315 · Lv et al., 2011 · Open in CIViC	civic
〃	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID4032 In a clinical study of 63 recurrent glioma patients, de novo glioblastoma patients treated with cetuximab monotherapy (n=27) and harboring IDH1 codon 132 mutation were associated with improved overal… (full text at CIViC) PMID 22199315 · Lv et al., 2011 · Open in CIViC	civic

AREG Expression2
Cetuximab + DocetaxelCombination	Head and Neck Squamous Cell Carcinoma	Predictive	B	Supports Resistance	2	accepted	EID846 47 HNSCC patients treated with cetuximab/docetaxel were retrospectively analyzed for EGFRvIII, EGFR and AREG expression with IHC. 45% of cases expressed high level of AREG. High AREG expression in tum… (full text at CIViC) PMID 21653686 · Tinhofer et al., 2011 · Open in CIViC	civic
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID788 226 cetuximab-treated patients with colorectal cancer (CRC) were analyzed for mRNA expression (by qPCR) of EGFR and its ligands (EGF, TGFA, AREG and EREG). High AREG mRNA expression in KRAS wild type … (full text at CIViC) PMID 23374602 · Pentheroudakis et al., 2013 · Open in CIViC	civic

EGFR C797S2
Brigatinib + CetuximabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	submitted	EID8028 Third generation EGFR inhibitor osimertinib can overcome the T790M resistance mutation on L858R or exon 19 del background. Drug screening of Ba/F3 cells expressing EGFR triple mutant (C797S/T790M/del1… (full text at CIViC) PMID 28287083 · Uchibori et al., 2017 · Open in CIViC	civic
Brigatinib + Cetuximab + PanitumumabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	submitted	EID4837 Currently, there are no effective therapeutic strategies to overcome the C797S/T790M/activating-mutation (triple-mutation)-mediated EGFR-TKI resistance to Osimertinib. In the present study, we identif… (full text at CIViC) PMID 28287083 · Uchibori et al., 2017 · Open in CIViC	civic