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.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer:  in combination with encorafenib and FOLFOX for the first line treatment; in combination with encorafenib in patients who have received prior systemic therapy.  For details, see section 5.1, for biomarker-based patient selection, see section 4.2.  Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck: in combination with radiation therapy for locally advanced disease; in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

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 18 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 201–250 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 G12/G133
Cetuximab	Malignant Colorectal Neoplasm

Clinical trials

Trials with this intervention (782)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–200 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
NCT06064877	A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma(FIERCE-HN)	recruiting	Phase 3	410	AVEO Pharmaceuticals, Inc.INDUSTRY	18	Apr 9, 2026	clinicaltrials
NCT07506109	A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer

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 21 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 G12 + KRAS G131
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID6296 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

KRAS G12 + KRAS G131

Cetuximab

Malignant Colorectal NeoplasmCURATED_BROADER

Predictive

Supports Resistance

accepted

EID6296

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