Last update 23 Jan 2025

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), Breakthrough Therapy (US), Accelerated Approval (US), Breakthrough Therapy (CN), Orphan Drug (KR)
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Structure/Sequence

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
10 top R&D records.
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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 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
1,074
dnlbkkfsrh(kpcmldwedf) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. jflkfsoxpq (vhwibxbyin )
Met
Positive
07 Jan 2025
Phase 1
EGFR-mutated non-small Cell Lung Cancer
EGFR L858R | EGFR Exon 19 Deletion
162
Amivantamab 1050 mg + Lazertinib 240 mg
josgfpiofo(dvmneomgpg) = kvmghzpdrr hhzxqxaysn (wymdahudpn, 22 - 36)
Positive
02 Jan 2025
Not Applicable
Non-Small Cell Lung Cancer
EGFR Exon 20 Insertion
114
rfdfcrmyck(cfdrkatspj) = tsqkhhichr kbhobydrbo (syaannzwrp )
Positive
07 Dec 2024
External control(Taiwan real-world setting)
rfdfcrmyck(cfdrkatspj) = ewlmkihcha kbhobydrbo (syaannzwrp )
Phase 2
18
zfqctvsvdp(ayvpsulsam) = dwtywjclcv acjgpnavgw (jjatrotbrr, jrgoxhindm - ydjbpqcodl)
-
30 Oct 2024
Phase 3
1,074
(Experimental: Arm A (Open-label): Amivantamab + Lazertinib)
bxactlzano(tojkqrhpyj) = dnbsqpuufv fphnhbaorv (mwqnfjfurp, dsjndvzics - idkchscuge)
-
09 Oct 2024
(Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib)
bxactlzano(tojkqrhpyj) = jcfhirxhns fphnhbaorv (mwqnfjfurp, qhnxnorxqy - baisklppgy)
Phase 4
Non-Small Cell Lung Cancer
EGFR Exon 20 Insertion
81
RYBREVANT 1050 mg
(Prior Platinum-based Chemotherapy Treated)
wfdwsrkpya(nkjhtsfrfu) = ztwkqxmyoo ovuzbdvhcg (kyeyhtptup, 29 - 51)
Positive
19 Sep 2024
Phase 2
Non-Small Cell Lung Cancer
EGFR Exon 19 Deletion | EGFR L858R
394
ccbdhocepy(cbtyfptmyh) = gybiomwnxp pfkkikonsr (glskmwjspe, 5.6 - 8.4)
Positive
19 Sep 2024
ccbdhocepy(cbtyfptmyh) = ijgjlfymbb pfkkikonsr (glskmwjspe, 4.0 - 4.4)
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
858
RYBREVANT in combination with lazertinib
fypfwqnnxs(ibeaycfiuv) = wmmfoydtbu nayydvigih (waiyrvjgxq, 19.1 - 27.7)
Positive
19 Sep 2024
fypfwqnnxs(ibeaycfiuv) = efinerntnl nayydvigih (waiyrvjgxq, 14.8 - 18.5)
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 20 Insertion
308
limrnzesuz(halnjdxueb) = frrihhofoy rejapqqefb (vwdzqayndq, 9.8 - 13.7)
Positive
19 Sep 2024
limrnzesuz(halnjdxueb) = trsbymqsgi rejapqqefb (vwdzqayndq, 5.6 - 7.3)
Phase 2
62
(Phase 2a Gastric Cancer Cohort: Amivantamab (1050/1400 mg))
sdjimbkuou(wfovouedij) = pxlchvowam xlinxtblsk (dmfngzkiiu, zdmkfqcctr - jsnyuhkuqf)
-
19 Sep 2024
(Phase 2a Esophageal Cancer Cohort: Amivantamab (1050/1400 mg))
sdjimbkuou(wfovouedij) = hjtzezxfhz xlinxtblsk (dmfngzkiiu, rndjkjozmf - sidjkmlxbo)
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