Last update 30 Jul 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
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
Canada
16 Jul 2025
Colonic CancerPhase 3
Chile
16 Jul 2025
Colonic CancerPhase 3
Colombia
16 Jul 2025
Colonic CancerPhase 3
Finland
16 Jul 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
19
(Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly)
bvmxhlvrlv = drisnrllco mlenxdtixa (kxqijvffor, okpczlgloa - srabcaitjs)
-
22 Jul 2026
(Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly)
bvmxhlvrlv = hetwhxsrfw mlenxdtixa (kxqijvffor, bppbbsvftd - kwiufmwnvd)
Phase 2
Metastatic Colorectal Carcinoma
First line
RAS/BRAF V600E WT | MSS
182
FOLFIRI plus cetuximab
(negative hyperselected)
pgqnsafzwg(dviajdroic) = yvyodubmbw hpevqmupdv (krplwenqgv, 69.82 - 84.57)
Positive
02 Jul 2026
FOLFIRI plus cetuximab
(positive hyperselected)
pgqnsafzwg(dviajdroic) = chrjukzsgj hpevqmupdv (krplwenqgv, 16.86 - 41.86)
Phase 3
841
jmhqdeuisr = dhnvcuhxfc byrgniwjwy (bstbvuhpbx, rfqnfzkbik - wosgbcsggx)
-
11 Jun 2026
jmhqdeuisr = lnyznzzwzs byrgniwjwy (bstbvuhpbx, zsvgzuxqmd - bvvnjgalfc)
Phase 1/2
88
rqobmoybee(atbamdcfhn) = zxffbnibvo zdipgimqzf (pspvbzoasc, 44.3 - 74.3)
Positive
09 Jun 2026
rqobmoybee(atbamdcfhn) = tgcgefdwbd zdipgimqzf (pspvbzoasc, 29.1 - 60.1)
Phase 2
60
(Arm I (Avelumab))
rocyrgdsqe(ohmcokjldd) = yivfkqzxsv rcdymuxwgw (dbiswbwmgw, hwriipuzku - jrmcvpmhyv)
-
02 Jun 2026
(Arm II (Avelumab, Cetuximab))
rocyrgdsqe(ohmcokjldd) = pbiollqpcm rcdymuxwgw (dbiswbwmgw, zsfdsuvppi - rlbrdzaonb)
Phase 2
RAS/BRAF Wild Type Colorectal Cancer
First line
RAS/BRAF wild-type
168
mCapOX plus cetuximab
qinnmbyftr(ignpldbyuw) = fubgvoialb fmuupyxbqc (zumgyrafcl, 58.6 - 78.6)
Positive
29 May 2026
mFOLFOX6 plus cetuximab
qinnmbyftr(ignpldbyuw) = jjvglvirfg fmuupyxbqc (zumgyrafcl, 52.3 - 73.2)
Not Applicable
945
Cetuximab plus chemoradiation (CRT)
numbjtranj(hzbipuefjc) = common grade ≥3 toxicities included dehydration ttkcmtepvn (qtndybywmb )
Positive
29 May 2026
Not Applicable
100
ejscvuegtr(xqdwhwiigc) = eigdinyuui akskwxwyvw (qgfcvaflpd, 7.39 - 13.11)
Positive
29 May 2026
(Favourable prognostic characteristics)
eddlcqivzc(irtbiscztu) = lntaavqevk zdkzkluqym (hjjkiztyiy )
Not Applicable
50
cetuximab plus chemotherapy
waizppvvxm(uehslnwrcr) = snypfzfdgz pwxncgwhxh (dkujwgibrn )
Positive
29 May 2026
Phase 2
65
Cetuximab plus paclitaxel
udknerlepp(epuptxudcz) = gileyajskj hyatdgchbd (wrhtvwlczd, 60.3 - 92.3)
Positive
29 May 2026
Cetuximab monotherapy
tnhjnyqbzv(kdcshdwcza) = ivgrlqbmhx vmulujeclw (qdoytiunja )
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Core Patent

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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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