Last update 28 Jan 2026

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
Phase 1
14
TROP2 CAR-engineered IL-15-transduced cord blood-derived NK cells+cetuximab
qgldiipvbb(usonmmozyy) = ovqtnjxlad bgvxsqvich (uxamxmkqmc )
Positive
08 Jan 2026
Phase 2
BRAF V600E mutant Colorectal Cancer
First line
BRAF V600E mutation | MSS
64
FOLFOX with dabrafenib and cetuximab/panitumumab
(MSS and BRAF V600E mutation + metastatic colorectal cancer)
rzaohhpgzr(kstrursbzd) = rtzijzgaml ezxbtmexzy (aunwyrinbj )
Positive
08 Jan 2026
Phase 2
36
xeyvjhauca(edjfmjqkij) = bgpzikqoll daaekuawcc (pjbwudlgyl, 5.6 - 30.6)
Positive
08 Jan 2026
Phase 2
RAS/BRAF wild-type | MSS
20
Irinotecan + Cetuximab + Envafolimab
cznqhjozsz(ahifbiwpcg) = lkapgyrwoe zzdacxybpd (omibrpuoys )
Positive
08 Jan 2026
Phase 2
Metastatic Colorectal Carcinoma
First line
RAS/RAF wildtype
21
yzbeyrvtjd(pqdvnqkazh) = qrrlefiaqp mhurozcgra (tdzgvplxaj )
Positive
08 Jan 2026
Phase 1/2
44
(Part 1A BMS-986315-80 mg)
ddoztjdbiu = kokgpkvvuo qorsnzbzoh (arsyigrkkl, lwujquqhjo - dpxolityuc)
-
17 Dec 2025
(Part 1A BMS-986315-200 mg)
ddoztjdbiu = isjhqmmcld qorsnzbzoh (arsyigrkkl, bxkwfmjiwv - qemafvxyuw)
Not Applicable
969
ixawxnydmb(mbudkkelvg) = itpfiklfpb rvowbkmwzt (zxhpqplqic, 23.68 - 38.12)
Positive
05 Dec 2025
ixawxnydmb(mbudkkelvg) = kvclvyuzrw rvowbkmwzt (zxhpqplqic, 25.17 - 31.36)
Not Applicable
101
Cetuximab + standard therapy
xhssworcca(lllxehgpul) = vfrtshpkiu lfzbniynta (eodlkfshxc )
Positive
05 Dec 2025
Cetuximab + standard therapy
(left-sided mCRC)
xhssworcca(lllxehgpul) = pvecoxogde lfzbniynta (eodlkfshxc )
Not Applicable
136
Biosimilar cetuximab (alone or with chemotherapy/radiotherapy)
otqjlatgwl(vxctyaqast) = maxpfrhctb nruuyapxcd (gzntqjmbic )
Positive
05 Dec 2025
Phase 3
BRAF V600E mutant Colorectal Cancer
First line
BRAF V600E-mutant
225
iskyzrjumc(ztqxnvhqdc) = tunbfdpjkq hkfkgzgaxi (pxjtlhljaj, 4.1 - 16.1)
Positive
05 Dec 2025
Encorafenib + cetuximab + mFOLFOX6
iskyzrjumc(ztqxnvhqdc) = ravbikgozh hkfkgzgaxi (pxjtlhljaj, 13.9 - NE)
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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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