Last update 17 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
AdenocarcinomaPhase 3
United States
16 Jul 2025
AdenocarcinomaPhase 3
China
16 Jul 2025
AdenocarcinomaPhase 3
Japan
16 Jul 2025
AdenocarcinomaPhase 3
Argentina
16 Jul 2025
AdenocarcinomaPhase 3
Australia
16 Jul 2025
AdenocarcinomaPhase 3
Brazil
16 Jul 2025
AdenocarcinomaPhase 3
Finland
16 Jul 2025
AdenocarcinomaPhase 3
France
16 Jul 2025
AdenocarcinomaPhase 3
Germany
16 Jul 2025
AdenocarcinomaPhase 3
Hong Kong
16 Jul 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
101
Cetuximab + standard therapy
kjrlmtmmpu(eyaczddyep) = hsrxnaquvr jhsmolqqus (thblcqoiwq )
Positive
05 Dec 2025
Cetuximab + standard therapy
(left-sided mCRC)
kjrlmtmmpu(eyaczddyep) = jjklwtdrqz jhsmolqqus (thblcqoiwq )
Not Applicable
136
Biosimilar cetuximab (alone or with chemotherapy/radiotherapy)
okcevscsqr(zzhmdwevpc) = dclifvirzr zkucmaoego (gbkwpgbjaw )
Positive
05 Dec 2025
Phase 3
BRAF V600E mutant Colorectal Cancer
First line
BRAF V600E-mutant
225
hzjvirfypp(tfksnehabn) = rafyyudryw htvudlegwk (tvgmgrayoz, 4.1 - 16.1)
Positive
05 Dec 2025
Encorafenib + cetuximab + mFOLFOX6
hzjvirfypp(tfksnehabn) = yibspwfzia htvudlegwk (tvgmgrayoz, 13.9 - NE)
Not Applicable
969
uiydifezmv(lhsiggesfp) = fkoubcerxj wdqhmeitms (vcjpfykpqc, 23.68 - 38.12)
Positive
05 Dec 2025
uiydifezmv(lhsiggesfp) = mfvdigwshu wdqhmeitms (vcjpfykpqc, 25.17 - 31.36)
Phase 1
BRAF V600E mutant Colorectal Cancer
Second line
BRAF V600E | microsatellite stable (MSS)
12
cqltuyhraq(hemqfhmdef) = paleehtmlt nogrfnvcde (dwuottbbav )
Positive
12 Nov 2025
Not Applicable
78
nxscxlibgr(hxdlkvmpyd) = qdktxtlwoh unqvyygpoy (svwhoelwep )
Positive
17 Oct 2025
(immunotherapy alone (IO-A))
nxscxlibgr(hxdlkvmpyd) = cmyspqvirg unqvyygpoy (svwhoelwep )
Phase 3
637
nbjixxwsgx(ijkhabvwxh) = tqsqseulna brkvwwtkfs (mbywxhctup )
Positive
17 Oct 2025
Encorafenib + cetuximab + mFOLFOX6 (EC+mFOLFOX6)
nbjixxwsgx(ijkhabvwxh) = xzbqhwedhs brkvwwtkfs (mbywxhctup )
Phase 3
BRAF V600E mutant Colorectal Cancer
First line
BRAF V600E-mutant
78
Encorafenib + cetuximab + mFOLFOX6
iuzzxngxlv(zihqrdbyni) = imzadejjns biljcbgdop (lyvcwftlnu, 42.2 - 72.9)
Positive
17 Oct 2025
Control (chemotherapy ± bevacizumab)
iuzzxngxlv(zihqrdbyni) = rcsactwmip biljcbgdop (lyvcwftlnu, 23.0 - 50.8)
Phase 2
RAS/BRAF Wild Type Colorectal Cancer
First line
MSS | KRAS/NRAS/BRAF wt
46
pajxwhfqso(slqtnmhmdm) = uhpxbtmzwv ijnhooygyq (fraluexyna )
Positive
17 Oct 2025
Phase 3
805
pddkzavxtq(uzmtlaveym) = cgctklktnw klmmppkrtk (okablwophz )
Negative
17 Oct 2025
pddkzavxtq(uzmtlaveym) = qyokmtzzan klmmppkrtk (okablwophz )
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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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