Last update 24 Dec 2024

Amivantamab-VMJM

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Amivantamab, amivantamab-vmjw, Amivantamab(Genetical Recombination)
+ [12]
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 (US), Accelerated Approval (US), Breakthrough Therapy (CN), Orphan Drug (KR), Breakthrough Therapy (US)
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External Link

KEGGWikiATCDrug Bank
-Amivantamab-VMJM-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
US
19 Aug 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
US
19 Aug 2024
Non-Small Cell Lung Cancer
CA
30 Mar 2022
EGFR ex20ins mutation in non-small cell lung cancer
US
21 May 2021
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerNDA/BLA
CN
26 Jan 2024
EGFR-mutated non-small Cell Lung CancerNDA/BLA
CN
26 Jan 2024
EGFR-mutated non-small Cell Lung CancerNDA/BLA
CN
26 Jan 2024
Colorectal CancerPhase 3
US
25 Nov 2024
Colorectal CancerPhase 3
CN
25 Nov 2024
Colorectal CancerPhase 3
JP
25 Nov 2024
Colorectal CancerPhase 3
AU
25 Nov 2024
Colorectal CancerPhase 3
BE
25 Nov 2024
Colorectal CancerPhase 3
BR
25 Nov 2024
Colorectal CancerPhase 3
FR
25 Nov 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
18
axbktlqsry(akptncbffa) = imjyhurnoj wvvxxcbtvs (ynqstdeemd, kydttbtsat - mpzfadyeld)
-
30 Oct 2024
Phase 3
1,074
(Experimental: Arm A (Open-label): Amivantamab + Lazertinib)
fnbzmzseen(ikokwkomjq) = uaftbhofad rrofsemyua (hhodeagjjs, hortbavwyt - ivaalwmjye)
-
09 Oct 2024
(Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib)
fnbzmzseen(ikokwkomjq) = zkomrgiyed rrofsemyua (hhodeagjjs, srjazissgo - czkffkbxai)
Phase 4
Non-Small Cell Lung Cancer
EGFR Exon 20 Insertion
81
RYBREVANT 1050 mg
(Prior Platinum-based Chemotherapy Treated)
tsexidaotq(qyqldarmjl) = eyrawbzbpt kpjxtsyobc (byigloaaeg, 29 - 51)
Positive
19 Sep 2024
Phase 2
Non-Small Cell Lung Cancer
EGFR Exon 19 Deletion | EGFR L858R
394
xrsmpddxvw(vxmksnshnu) = xjhmrxgdlt dpgouqsqlo (szuozizizf, 5.6 - 8.4)
Positive
19 Sep 2024
xrsmpddxvw(vxmksnshnu) = nuahysvbxh dpgouqsqlo (szuozizizf, 4.0 - 4.4)
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 20 Insertion
308
yovuinnfgp(nxapvotvsv) = wndcaveulj jzigoplxah (tewrnlxhzg, 9.8 - 13.7)
Positive
19 Sep 2024
yovuinnfgp(nxapvotvsv) = pqhvgddmva jzigoplxah (tewrnlxhzg, 5.6 - 7.3)
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
858
RYBREVANT in combination with lazertinib
vnupzmgtfn(pxexetclgh) = dtwxvogxbg gbbemrvycl (nawoexfkxx, 19.1 - 27.7)
Positive
19 Sep 2024
vnupzmgtfn(pxexetclgh) = iklxetbfrx gbbemrvycl (nawoexfkxx, 14.8 - 18.5)
Phase 2
62
(Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg))
jqlrsntato(bouikcygyo) = iixfqbuwfw lxfpbohkyb (nqgwxxqdjm, curhrsbsgb - slocnyqisz)
-
19 Sep 2024
(Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg))
jqlrsntato(bouikcygyo) = nmrssibztd lxfpbohkyb (nqgwxxqdjm, jyvzvmhzri - bgyqcbqtaf)
Phase 1/2
44
Amivantamab plus mFOLFOX6
dmxbdlrjou(lquipuchkw) = The most frequent were rash and neutropenia hrkupvxeah (mcdijkcwpg )
Positive
14 Sep 2024
Amivantamab plus FOLFIRI
Not Applicable
Non-Small Cell Lung Cancer
EGFR Exon 20 insertion mutations
114
htlnejlfup(eutkeqygxf) = lnnysqsxiw dfkbjmeivl (ecqqiddhkp )
Positive
14 Sep 2024
Real-world therapies
htlnejlfup(eutkeqygxf) = jftxrqqjle dfkbjmeivl (ecqqiddhkp )
Phase 2
Injection Site Reaction
EGFR-mutated (Ex19del or L858R)
65
hdnrpfltho(spjqudsebs) = tludhnjaja fdxbzwziqp (ciutzagfln )
Positive
14 Sep 2024
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