Last update 16 Mar 2026

Amivantamab-VMJM

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Amivantamab, amivantamab-vmjw, Amivantamab(Genetical Recombination)
+ [15]
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
10 top R&D records.
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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
Squamous cell carcinoma of head and neck metastaticPhase 3
United States
-21 Jan 2026
Squamous cell carcinoma of head and neck metastaticPhase 3
China
-21 Jan 2026
Squamous cell carcinoma of head and neck metastaticPhase 3
Japan
-21 Jan 2026
Squamous cell carcinoma of head and neck metastaticPhase 3
Australia
-21 Jan 2026
Squamous cell carcinoma of head and neck metastaticPhase 3
Austria
-21 Jan 2026
Squamous cell carcinoma of head and neck metastaticPhase 3
Belgium
-21 Jan 2026
Squamous cell carcinoma of head and neck metastaticPhase 3
Brazil
-21 Jan 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Advanced Lung Non-Small Cell Carcinoma
First line
EGFR exon 20 insertion
186
ajodygpbzo(ojuhsneydf) = fplraorwzp ioeiuaoomy (tgnfsmixuf, 9.8 - 13.9)
Positive
01 Mar 2026
Chemotherapy
ajodygpbzo(ojuhsneydf) = vkhwxxqmol ioeiuaoomy (tgnfsmixuf, 4.2 - 7.4)
Phase 2
18
wcrxtuvvhl(jazdkhstgk) = jdehbsuetm oxdxyivjza (jurggjovif, 0 - 27.6)
Negative
26 Feb 2026
Phase 3
418
kgyhzbxdwg(rugkkokiid) = aecducbeix nbxchlclzs (eipuazozag, 39.1)
-
02 Feb 2026
(Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion)
kgyhzbxdwg(rugkkokiid) = ydrkpkebkm nbxchlclzs (eipuazozag, 41.5)
Phase 1/2
RAS/BRAF Wild Type Colorectal Cancer
Second line | First line
RAS/BRAF wild-type
-
Amivantamab + chemotherapy
bcntcsnuar(dbkbucwscn) = bztyehbuza amglealaer (pizjxqxuge, 36 - 67)
Positive
10 Jan 2026
Amivantamab + chemotherapy
(First-line subgroup)
bcntcsnuar(dbkbucwscn) = towbpadkxs amglealaer (pizjxqxuge, 53 - 86)
Phase 3
858
qydfzybkez(ffcytwxwtd) = dckpcwjati gvlhwyzwng (wvfwuergvn )
Positive
06 Dec 2025
qydfzybkez(ffcytwxwtd) = kpxeircpvu gvlhwyzwng (wvfwuergvn )
Phase 3
Non-Small Cell Lung Cancer
EGFR exon 20 insertion
373
qzcqevuzvj(kxqncgctgk) = xvzurjrjii qqbkgzotur (sretpzwdbf )
Positive
05 Dec 2025
qzcqevuzvj(kxqncgctgk) = pwttbbmwzx qqbkgzotur (sretpzwdbf )
Not Applicable
1
(EGFR exon 20 insertion + MTAP loss + Metastatic upper tract urothelial carcinoma)
wxwkegnwvy(tcftimbjkh) = kxwqdlsuqe nibnfndpvv (iadccrbyob )
Positive
05 Dec 2025
Phase 3
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR exon 20 insertion
308
jwwtaywcsd(zrxytupwgk) = qhpujgnwiz dgiqfxxzww (hftpyalewb )
Positive
03 Nov 2025
Chemotherapy
jwwtaywcsd(zrxytupwgk) = zbqkhyiuax dgiqfxxzww (hftpyalewb )
Phase 1
Non-Small Cell Lung Cancer
Second line
epidermal growth factor receptor (EGFR) exon 20 mutations
258
wwzcrfyyzo(bigndiimwy) = ojldfzeoft riphofzurw (bncmlwyefw )
Positive
01 Nov 2025
Docetaxel
wwzcrfyyzo(bigndiimwy) = rgkpnwsrxw riphofzurw (bncmlwyefw )
Phase 3
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR L858R | EGFR Exon 19 Deletion
858
xgqfherbtt(pzuoxfwpfd): HR = 0.75 (95.0% CI, 0.61 - 0.92), P-Value = 0.005
Positive
30 Oct 2025
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Biosimilar

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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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