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.

health-canada-dpdRegulatory15 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ERBITUX (DIN 02271249) under ATC L01FE01 CETUXIMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 28, 2008	health-canada-dpd
EU

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 9 hours 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 51–100 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 D594G2
Cetuximab + Irinotecan

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
NCT05355701	A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.	active not recruiting	Phase 1	103	PfizerINDUSTRY	3	Sep 1, 2026	clinicaltrials
NCT07042295	Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System	suspended

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 12 hours 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

BRAF Mutation4
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID6306 This was a retrospective clinical study of 92 metastatic colorectal cancer patients who received cetuximab in conjunction with salvage chemotherapy (refractory to at least one line of treatment). Salv… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID1704 A cohort of patient-derived xenografts (PDX) from 85 patients with metastatic colorectal cancer was created. PDX were treated with cetuximab and mechanisms of resistance investigated. None of the xeno… (full text at CIViC) PMID 22586653 · Bertotti et al., 2011 · Open in CIViC	civic
Cetuximab + ChemotherapyCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID2187 This was a retrospective study of 350 patients with metastatic, chemotherapy refractory colorectal cancer treated with cetuximab + chemotherapy who had individual response data and whose tumors were K… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID1404 A quantitative synthesis was performed on nine studies comparing treatment of metastatic colorectal cancer with cetuximab or panitumumab and chemotherapy, versus chemotherapy alone, or with other targ… (full text at CIViC) PMID 25673558 · Pietrantonio et al., 2015 · Open in CIViC	civic

BRAF V6004
Cetuximab + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1598 Patients with BRAF-V600 mutated cancers were identified (n=122) and subsequently underwent targeted therapy. 27 patients with colorectal cancer were treated with vemurafenib and cetuximab (N=24 with B… (full text at CIViC) PMID 26287849 · Hyman et al., 2015 · Open in CIViC	civic
Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID6046 In a Phase Ib Dose-Escalation Study of Encorafenib and Cetuximab, Twenty-six patients with refractory BRAF V600 mutant metastatic CRC (mCRC) were treated with a selective RAF kinase inhibitor (encoraf… (full text at CIViC) PMID 28363909 · van Geel et al., 2017 · Open in CIViC	civic
Alpelisib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID6047 In a phase Ib dose-escalation study of encorafenib, cetuximab and alpelisib, twenty-eight patients with refractory BRAF V600-mutant metastatic CRC (mCRC) were treated with a selective RAF kinase inhib… (full text at CIViC) PMID 28363909 · van Geel et al., 2017 · Open in CIViC	civic
Cetuximab + Irinotecan + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID7355 A randomized clinical trial was done with metastatic colorectal cancer (mCRC) patients (50 in the control group, 49 in the experimental group) with BRAF V600 mutations and RAS wild type that were enro… (full text at CIViC) Open in CIViC	civic

BRAF V600E18
Binimetinib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID7260 In a phase III trial, patients with BRAF V600E mutated metastatic colorectal cancer received triplet combination with encorafenib + binimetinib + cetuximab in a second or third-line setting. In the sa… (full text at CIViC) Open in CIViC	civic
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID126 This was a retrospective study of 691 cetuximab treated patients with metastatic, chemotherapy refractory colorectal cancer. Of those, 30 patients harbored BRAF V600E, were KRAS, NRAS and PIK3CA wt, a… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	—	submitted	EID3736 In metastatic colorectal cancer patients with wildtype KRAS status who received cetuximab therapy, those with a BRAF V600E mutation had reduced progression-free survival (8.0wk vs. 31.4wk, P=0.001, lo… (full text at CIViC) PMID 19884556 · Laurent-Puig et al., 2009 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	submitted	EID3737 In metastatic colorectal cancer patients with wildtype KRAS status who received cetuximab therapy, those with a BRAF V600E mutation had reduced progression-free survival (8.0wk vs. 31.4wk, P=0.001, lo… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	submitted	EID3740 In a retrospective study of 53, KRAS exon 2 wild-type, metastatic colorectal cancer patients, patients harboring BRAF G466A (n=1), G469A (n=2), D594G (n=1), or V600E (n=2) mutations were reported to b… (full text at CIViC) PMID 26989027 · Hsu et al., 2016 · Open in CIViC	civic
Bevacizumab + Capecitabine + Cetuximab + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	submitted	EID8646 In a study of metastatic colorectal cancer patients treated with capecitabine, oxaliplatin, bevacizumab, and cetuximab those with BRAF V600E mutations had reduced progression-free survival (6.6mo vs. … (full text at CIViC) PMID 19571295 · Tol et al., 2009 · Open in CIViC	civic
Cetuximab + Encorafenib + NivolumabCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID12624 In a single-arm phase 1/2 trial in microsatellite stable BRAF V600E metastatic colorectal cancer (NCT04017650; n = 26), combination encorafenib + cetuximab + nivolumab achieved an ORR of 50 % among ev… (full text at CIViC) PMID 40882637 · Morris et al., 2025 · Open in CIViC	civic
Cetuximab + FOLFOX-4 RegimenCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	4	accepted	EID3739 In a retrospective study of 148 treatment naive metastatic colorectal cancer patients, patients with BRAF V600E and wildtype NRAS/KRAS (n=14) mutation treated with FOLFOX4 plus cetuximab were associat… (full text at CIViC) PMID 25666295 · Kaczirek et al., 2015 · Open in CIViC	civic
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	submitted	EID3738 In a retrospective study of 68 irinotecan-refractory metastatic colorectal cancer patients, the tumors of eight patients harbored BRAF V600E but were wildtype for KRAS codons 12, 13, 61 and 146 mutati… (full text at CIViC) PMID 19603018 · Loupakis et al., 2009 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Resistance	4	accepted	EID816 This meta-analysis of 7 randomized control trials evaluating overall survival (OS) (8 for progression free survival) could not definitely state that survival benefit of anti-EGFR monoclonal antibodies… (full text at CIViC) PMID 25989278 · Rowland et al., 2015 · Open in CIViC	civic
Binimetinib + Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	accepted	EID7612 665 patients with BRAF V600E-mutated metastatic CRC were enrolled In this open-label, phase 3 trial. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuximab… (full text at CIViC) PMID 31566309 · Kopetz et al., 2019 · Open in CIViC	civic
Cetuximab + EncorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID9851 The open-label phase 3 BEACON CRC trial included 665 patients with BRAF V600E-mutated metastatic CRC. Patients were randomly assigned in a 1:1:1 ratio to receive encorafenib, binimetinib, and cetuxima… (full text at CIViC) PMID 31566309 · Kopetz et al., 2019 · Open in CIViC	civic
Cetuximab + Encorafenib + Fluorouracil + Leucovorin + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	submitted	EID13309 In the randomized phase 3 BREAKWATER trial, previously untreated patients with BRAF V600E-mutated metastatic colorectal cancer receiving first-line encorafenib, cetuximab, and mFOLFOX6 (n=236) had sig… (full text at CIViC) PMID 40444708 · Elez et al., 2025 · Open in CIViC	civic
Cetuximab + Irinotecan + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID8506 This in vivo study examined the efficacy of various treatments on athymic nude mice xenografted with colorectal cancer HT29 cells, which harbor BRAF V600E. The authors sought to understand whether the… (full text at CIViC) PMID 22180495 · Yang et al., 2012 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID2115 In metastatic colorectal cancer patients with wildtype KRAS status, those with a BRAF V600E mutation were less likely to respond to treatment with cetuximab or panitumumab than those with wildtype BR… (full text at CIViC) PMID 19001320 · Di Nicolantonio et al., 2008 · Open in CIViC	civic
Cetuximab + SorafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID2894 Cetuximab or panitumumab may be ineffective in patients with BRAF mutation unless BRAF inhibitor such as Sorafenib is introduced. PMID 19001320 · Di Nicolantonio et al., 2008 · Open in CIViC	civic
Cetuximab + Irinotecan + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1902 Phase 1b study of vemurafenib, cetuximab and irinotecan in 19 patients with colorectal cancer (1 with appendiceal cancer). Six of 17 evaluable patients achieved an objective response, 15 patients tota… (full text at CIViC) PMID 27729313 · Hong et al., 2016 · Open in CIViC	civic
Cetuximab + Gefitinib + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1408 5 of 7 colorectal cancer (CRC) cell lines with BRAF V600E mutation were resistant to treatment with the BRAF inhibitor vemurafenib. An RNAi screen in the WiDr cell line (a V600E CRC line) identified E… (full text at CIViC) PMID 22281684 · Prahallad et al., 2012 · Open in CIViC	civic

EGFR Amplification2
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID911 87 patients with metastatic colorectal cancer treated with cetuximab were retrospectively analyzed for EGFR amplifications by FISH. In multivariate analysis, EGFR amplification predicted response and … (full text at CIViC) PMID 18794099 · Personeni et al., 2008 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID854 In this meta-analysis (14 studies, 1021 patients), EGFR gene copy number (GCN) was predictive of improved progression free survival (PFS) and overall survival (OS) with cetuximab or panitumumab regard… (full text at CIViC) PMID 24653627 · Shen et al., 2014 · Open in CIViC	civic

EGFR Expression2
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1572 Patients with refractory colorectal cancer expressing immunohistochemically detectable EGFR were randomly assigned to receive treatment with cetuximab (n=287) or receive supportive care alone (n=285).… (full text at CIViC) PMID 18003960 · Jonker et al., 2007 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	1	accepted	EID1709 57 patients with chemorefractory colorectal cancer expressing EGFR (IHC staining) were treated with single-agent cetuximab in this phase 2 study. Five patients (9%; 95% CI, 3% to 19%) achieved a parti… (full text at CIViC) PMID 14993230 · Saltz et al., 2004 · Open in CIViC	civic