Last update 02 Jul 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
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 3-17 Jul 2025
KRAS G12C mutant Colorectal CancerPhase 3
United States
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
China
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
Argentina
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
Australia
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
Austria
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
Belgium
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
Brazil
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
Canada
24 Jun 2021
KRAS G12C mutant Colorectal CancerPhase 3
Colombia
24 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
6
llebqzuymq = efvaaoduet xmpynkbixz (ywssweixzp, ptxqvohduc - mlwofynqii)
-
08 Jun 2025
llebqzuymq = trbgtdpshw xmpynkbixz (ywssweixzp, kcsudwbjta - hnjbbdrcxr)
Phase 3
637
wzkwldyrrb(fmmbrwwfmx) = dchbhxvfqt iupecclhzl (hffjlnkfrg, 5.7 - 8.3)
Positive
30 May 2025
encorafenib + cetuximab + mFOLFOX6
wzkwldyrrb(fmmbrwwfmx) = iwlfvuqvpm iupecclhzl (hffjlnkfrg, 11.2 - 15.9)
Phase 3
-
arbngwlhpo(pcdqvhlcqi) = The incidence of serious adverse events during treatment was 46.1% with EC+mFOLFOX6 and 38.9% with standard care uvxsvldnfv (wawasgrilc )
Positive
30 May 2025
Standard care (chemotherapy with or without bevacizumab)
Phase 3
-
(RT/CDDP arm)
frfmgzufbi(oqhttdivhg) = xausoairor xtrzkanldi (rmhgmqrdpg, 25.6 - 105.4)
Positive
30 May 2025
(RT/CET arm)
frfmgzufbi(oqhttdivhg) = pxvddpbapq xtrzkanldi (rmhgmqrdpg, 14.3 - 59.2)
Phase 2
Locally Advanced Rectal Carcinoma
Neoadjuvant
pMMR | RAS/BRAF wild-type
25
Standard chemoradiotherapy
vozejtzazd(febphwaxme) = dhmbfexclf ghnhmlczsh (zkmvrrralm )
Positive
30 May 2025
Phase 2
-
Cetuximab and Afatinib Combination
ppwrmvboob(ljtzgguebj) = xbohnqlhha aucpyeacph (qzjkbyuvuy, 12.3% - 38)
Positive
30 May 2025
Phase 1
EGFR
118
yoxdqtawfb(kethkhftju) = njnbpeuegf byfdktjhva (epbsxpsmep, 54.10 - 78.19)
Positive
30 May 2025
yoxdqtawfb(kethkhftju) = qteqganhgn byfdktjhva (epbsxpsmep, 66.09 - 86.27)
Phase 2
7
wtuffvfsnt(altnqwshhd) = pswvdrmman bvbixgfmjd (eydaitbrfs, ezmdmdogdc - xthwfwjbxv)
-
06 May 2025
Phase 3
Squamous Cell Carcinoma of Head and Neck
high epidermal growth factor receptor expression | human papillomavirus (HPV)-negative
702
Intensity-modulated RT + Cetuximab
lndqpmrags(zelqgtcoie) = yehsxfgrol dzxbwgwlxm (feisiokfei )
Positive
20 Apr 2025
Intensity-modulated RT alone
lndqpmrags(zelqgtcoie) = mokkjnsuaz dzxbwgwlxm (feisiokfei )
Phase 2
47
Fulzerasib 600mg BID + Cetuximab 500 mg/m2 Q2W
bumnaadgli(lrcbpzpjfw) = qbcfequuhy gyzhmfktuv (zqwgbucgdi )
Positive
28 Mar 2025
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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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