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 301–350 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
KRAS Q61P2
Cetuximab	Malignant Colorectal Neoplasm

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

KRAS Q61R3
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	submitted	EID2229 In irinotecan-resistant metastatic colorectal cancer patients who had been treated with cetuximab and irinotecan, KRAS mutations in codon 61 or 146 were associated with shorter progression-free surviv… (full text at CIViC) PMID 19603018 · Loupakis et al., 2009 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	submitted	EID3869 In a retrospective study of 138 metastatic irinotecan-refractory, colorectal cancer patients, patients with a KRAS codon 61 or 146 mutation (8/68) treated with cetuximab plus chemotherapy were associa… (full text at CIViC) PMID 19603018 · Loupakis et al., 2009 · Open in CIViC	civic
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID3870 Two patients participating in a large retrospective trial of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored KRAS Q61R and were wild type for PIK3CA, BRAF, an… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic

NRAS G12C2
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	—	submitted	EID3846 In an in vitro study, an OXCO-2 cell line expressing NRAS G12C mutation demonstrated acquired resistance after low level cetuximab exposure compared to OXCO-2 parental cells expressing NRAS wild-type.… (full text at CIViC) PMID 24553387 · Misale et al., 2014 · Open in CIViC	civic
Cetuximab + ChemotherapyCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID3845 Two patients participating in a large retrospective trial of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored NRAS G12C and were wild type for KRAS, PIK3CA, an… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic

NRAS G12D4
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	—	accepted	EID3693 In a retrospective study of 148 treatment naive metastatic colorectal cancer patients, patients with RAS mutations (n=10), including KRAS A146T, KRAS G13D, NRAS G12D and NRAS Q179*, treated with FOLFO… (full text at CIViC) PMID 25666295 · Kaczirek et al., 2015 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	—	submitted	EID3691 In an in vitro study, an OXCO-2 cell line expressing NRAS G12D mutation demonstrated acquired resistance after low level cetuximab exposure compared to OXCO-2 parental cells expressing NRAS wild-type.… (full text at CIViC) PMID 24553387 · Misale et al., 2014 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	—	submitted	EID3692 In 28 out of 40 (70%) metastatic colorectal cancer tumors implanted into mice, the therapeutic combination of the MEK inhibitor AZD6244 and the PI3K/mTor inhibitor BEZ235 resulted in disease stabiliza… (full text at CIViC) PMID 22392911 · Migliardi et al., 2012 · Open in CIViC	civic
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID2002 One patient participating in a large retrospective trial of cetuximab in metastatic, treatment refractory colorectal cancer had a tumor which harbored NRAS G12D and was wild type for KRAS, PIK3CA, and… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic

NRAS Mutation3
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID1703 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	2	accepted	EID2210 This was a retrospective study of 605 patients with metastatic, chemotherapy refractory colorectal cancer treated with cetuximab + chemotherapy. Patients with KRAS wildtype, NRAS assessable tumors, an… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	A	Supports Resistance	4	accepted	EID5344 NCCN guidelines indicate colorectal cancer patients with NRAS mutations should not be treated with EGFR inhibitors cetuximab or panitumumab. PMID 28275037 · Benson et al., 2017 · Open in CIViC	civic

NRAS Q612
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Resistance	3	accepted	EID124 In chemotherapy-refractory patients with colorectal cancer, NRAS mutation status (primarily Q61, N=13) was not informative for disease control rate, progression free survival or overall survival follo… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
Cetuximab + ChemotherapyCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	2	accepted	EID36 Chemotherapy-refractory patients with KRAS wt metastatic colorectal cancer harboring NRAS mutation (primarily Q61, n=10) have a significantly lower response rate to cetuximab than patients wildtype fo… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic