Last update 09 Dec 2025

Cetuximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-EGFR monoclonal antibody 225, Cetuximab (Genetical Recombination), Cetuximab (genetical recombination) (JAN)
+ [16]
Target
Action
antagonists
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Switzerland (01 Dec 2003),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D03455Cetuximab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
BRAF V600E mutant Colorectal Cancer
China
30 Sep 2025
RAS Wild Type Colorectal Cancer
Australia
25 Sep 2007
Head and Neck Neoplasms
United States
01 Mar 2006
Metastatic Colorectal Carcinoma
European Union
29 Jun 2004
Metastatic Colorectal Carcinoma
Iceland
29 Jun 2004
Metastatic Colorectal Carcinoma
Liechtenstein
29 Jun 2004
Metastatic Colorectal Carcinoma
Norway
29 Jun 2004
Squamous Cell Carcinoma of Head and Neck
European Union
29 Jun 2004
Squamous Cell Carcinoma of Head and Neck
Iceland
29 Jun 2004
Squamous Cell Carcinoma of Head and Neck
Liechtenstein
29 Jun 2004
Squamous Cell Carcinoma of Head and Neck
Norway
29 Jun 2004
Colorectal Cancer
Switzerland
01 Dec 2003
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Colonic CancerPhase 3
United States
16 Jul 2025
Colonic CancerPhase 3
China
16 Jul 2025
Colonic CancerPhase 3
Japan
16 Jul 2025
Colonic CancerPhase 3
Argentina
16 Jul 2025
Colonic CancerPhase 3
Australia
16 Jul 2025
Colonic CancerPhase 3
Brazil
16 Jul 2025
Colonic CancerPhase 3
Finland
16 Jul 2025
Colonic CancerPhase 3
France
16 Jul 2025
Colonic CancerPhase 3
Germany
16 Jul 2025
Colonic CancerPhase 3
Hong Kong
16 Jul 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
BRAF V600E mutant Colorectal Cancer
Second line
BRAF V600E | microsatellite stable (MSS)
12
aguhmxllrc(xzibdxkwff) = cvitjzrqas ckufszlxbu (xzuvyaxjzk )
Positive
12 Nov 2025
Phase 3
BRAF V600E mutant Colorectal Cancer
First line
BRAF V600E-mutant
78
Encorafenib + cetuximab + mFOLFOX6
irjgfntjfu(deyqsmmlxj) = uumnefrlpd mzajehjyqg (hnzslqayjv, 42.2 - 72.9)
Positive
17 Oct 2025
Control (chemotherapy ± bevacizumab)
irjgfntjfu(deyqsmmlxj) = myeibhpylt mzajehjyqg (hnzslqayjv, 23.0 - 50.8)
Phase 3
805
gqignyjosb(xwibbiydze) = pcmyiwibxx rkkhjepgze (tmftzothco )
Negative
17 Oct 2025
gqignyjosb(xwibbiydze) = glazgqrqag rkkhjepgze (tmftzothco )
Phase 3
637
vwxgkqvami(xsizhpdkzd) = yfouyffybn uoijhvbahz (pnyelresze )
Positive
17 Oct 2025
Encorafenib + cetuximab + mFOLFOX6 (EC+mFOLFOX6)
vwxgkqvami(xsizhpdkzd) = greqokfofx uoijhvbahz (pnyelresze )
Phase 2
RAS/BRAF Wild Type Colorectal Cancer
First line
MSS | KRAS/NRAS/BRAF wt
46
zjlqmyrkch(qcpusxkkob) = agiryjtxqd xomyozkbrc (gazqjtafsx )
Positive
17 Oct 2025
Not Applicable
78
imlzjibmvb(rwelsqqemf) = ihnsmauspl yqjaeojwzm (zoewodwqtr )
Positive
17 Oct 2025
(immunotherapy alone (IO-A))
imlzjibmvb(rwelsqqemf) = jxhqoruqpt yqjaeojwzm (zoewodwqtr )
Phase 2
RAS/BRAF Wild Type Colorectal Cancer
KRAS/NRAS/BRAF wild-type
12
xshsekygut(scmncrfuqx) = wwzubishpi qsjicrelnx (nmbexmfdqy, 15 - 72)
Negative
01 Oct 2025
Phase 1/2
5
ridlkfxcqf = byijxpursi lcxnonikyo (pyrxzwptav, gmpvjcqabv - kcxnfkfbhd)
-
22 Jul 2025
Phase 2
57
djhpvgdvsb(mgdaflfple) = nvlogfacws dagrliswge (ssjreingeq, 7.6 - NR)
Positive
20 Jul 2025
djhpvgdvsb(mgdaflfple) = xhqdlbibrr dagrliswge (ssjreingeq, 2.7 - 13.6)
Phase 3
243
mkupodacaq(ikpfowbkiy) = agnqojfart qjunwpgvyw (ncwnwfrdeg, 43.3 - 67.8)
Positive
03 Jul 2025
mkupodacaq(ikpfowbkiy) = zncrkoygab qjunwpgvyw (ncwnwfrdeg, 29.1 - 48.1)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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