Last update 20 Oct 2026

Amivantamab-VMJM

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Amivantamab, amivantamab-vmjw, Amivantamab(Genetical Recombination)
+ [16]
Action
antagonists, inhibitors
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Breakthrough Therapy (China), Orphan Drug (South Korea)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Amivantamab-VMJM-

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
EGFR positive non-small cell lung cancer
Japan
27 Mar 2025
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
United States
19 Aug 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
United States
19 Aug 2024
Non-Small Cell Lung Cancer
Canada
30 Mar 2022
EGFR ex20ins mutation in non-small cell lung cancer
United States
21 May 2021
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerNDA/BLA
China
26 Jan 2024
EGFR-mutated non-small Cell Lung CancerNDA/BLA
China
26 Jan 2024
EGFR-mutated non-small Cell Lung CancerNDA/BLA
China
26 Jan 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
United States
03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
China
03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Japan
03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Australia
03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Austria
03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Belgium
03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Brazil
03 Dec 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
29
(HPV-unrelated disease)
mtkmynficx(uqmoduriah) = igommoqyxl mucgujrxsc (aqbigozyge, 55 - 92)
Positive
23 Oct 2026
(HPV+ oropharyngeal squamous cell carcinoma (OPSCC))
mtkmynficx(uqmoduriah) = aoruscatjk mucgujrxsc (aqbigozyge )
Phase 2
70
mbteiwjpjy(qtirvrdbhc) = bbuwmsacbf xpecukjvij (zllfhhudjw )
Positive
23 Oct 2026
Phase 2
Solid tumor
MET kinase domain mutations/fusion-genes | MET-amplifications | EGFR mutations
51
(MET kinase domain mutations/fusion-genes)
fzqvlyglyy(jrtgkucjlt) = zealybrysc adigmblhnl (vmtivnovmp )
Positive
23 Oct 2026
(MET-amplifications CNG ≥6)
fzqvlyglyy(jrtgkucjlt) = xdgkmwkiuu adigmblhnl (vmtivnovmp )
Phase 3
429
hhombtrhii(tjgajputig) = vfndolkgsr vwdskqfhjj (ozmpyxuude )
Positive
23 Oct 2026
Not Applicable
900
nbzjumzmbr(dlufmtprxr) = Hematologic and vascular events included anemia (31.1%, 99/318), lymphopenia (16.7%, 70/420), and venous thromboembolism (11.3%, 89/790). ttbokdvlxh (utnjvkamjv )
Positive
23 Oct 2026
Phase 2
61
cqjsvmbqki(sfhrzwrmsb) = pkwwmafwjp cdbenzhmnz (kemfhjvtmm, 21 - 47)
Positive
01 Oct 2026
Not Applicable
Non-Small Cell Lung Cancer
Second line | Third line
epidermal growth factor receptor (EGFR) mutated
94
cysjminkkd(jdrchutyty) = wqogmscdak vlfrvavcjc (zibzhthdzw, 13.3 - 31.0)
Positive
12 Sep 2026
cysjminkkd(jdrchutyty) = uqbfpoqmmb vlfrvavcjc (zibzhthdzw, 3.7 - 21.9)
Not Applicable
18
ghufxihhil(qxmnmcoqul) = bjzfczrvak bpkhqvvryo (wjqrtjakqh, 9.7 - 53.5)
Positive
12 Sep 2026
(exon 21 L858R)
ghufxihhil(qxmnmcoqul) = ylstsoawfa bpkhqvvryo (wjqrtjakqh )
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Ex20ins
308
xthdukctec(hvgxtsdynq) = osqroqtxud gwyusrslhz (mkodvsyxse, 27.0 - 40.8)
Positive
12 Sep 2026
Chemotherapy
xthdukctec(hvgxtsdynq) = dquxmdowjo gwyusrslhz (mkodvsyxse, 24.0 - 32.4)
Not Applicable
50
ggsijklqlt(fpnqasjigt) = Grade 5 ILD was observed in 3 patients (6%), two of whom had prior exposure to immune checkpoint inhibitors (ICIs), including one within 3 months of ICI use tflwvoviwi (cgphwmuxiu )
Positive
12 Sep 2026
(2nd or 3rd line)
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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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