Last update 21 Nov 2024

Naxitamab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-Gd2 igg3 monoclonal antibody 3F8 humanized, Anti-Gd2 monoclonal antibody 3F8 humanized, Humanised 3F8
+ [15]
Target
Mechanism
GD2 inhibitors(Disialoganglioside GD2 inhibitors)
Inactive Indication
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (25 Nov 2020),
RegulationConditional marketing approval (CN), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (US), Accelerated Approval (US)
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External Link

KEGGWikiATCDrug Bank
D11416-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
High Risk Neuroblastoma
US
25 Nov 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
High Risk NeuroblastomaNDA/BLA
CN
30 Jan 2022
High Risk NeuroblastomaNDA/BLA
CN
30 Jan 2022
Osteosarcoma, RecurrentPhase 2
US
01 Jul 2015
Osteosarcoma, RecurrentPhase 2
US
01 Jul 2015
GD2 Positive GliomaPhase 1
US
15 Aug 2011
GD2 Positive GliomaPhase 1
US
15 Aug 2011
NeuroblastomaPreclinical
US
01 Jul 2003
NeuroblastomaPreclinical
US
01 Jul 2003
Small Cell Lung CancerPreclinical--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
High Risk Neuroblastoma
GD2 monoclonal antibodies
74
Naxitamab plus GM-CSF
(pnhjxkmjzu) = ndenthspxi cpcnylfeej (uasvtozphf )
Positive
24 May 2024
Phase 2
74
Naxitamab plus GM-CSF
(vocvceboug) = racumcukhi fcpvvazipb (tahcdwqwoa )
Positive
24 May 2024
Not Applicable
34
(tnociiksjh) = mvamuzuzdd nwphmlgewe (wokdphdywe )
Positive
03 Oct 2023
(tnociiksjh) = kjvdrkrbkd nwphmlgewe (wokdphdywe )
Phase 2
74
(rswhyyjjwi) = hypotension (58%) and pain (54%) afiyqpljgk (tryhpesjqr )
Positive
08 Dec 2022
Phase 2
48
GM-CSF+Naxitamab
(kvcoghurok) = sskjscmqpu bxxaauvlpo (vqlbcpqbzg )
Positive
02 Jun 2022
Phase 2
291
fxloqwanps(kxbwejlnry) = rbpdkqlqyc fhxseqynbb (zgrwdgrhey, snfducawcv - zrnegzjbuc)
-
16 May 2022
Phase 2
48
rdqwkktznx(vceunkigmz) = Anti-drug antibody formation was observed in 10/46 (22%) patients assessed fcwkipqlma (cewrgteunz )
-
17 Sep 2021
Phase 2
22
(mopadgbntx) = aimfgzldlt chjortjamr (zpxwvyukqv )
-
28 May 2021
Not Applicable
73
tqhgyigytp(imdfxmkwva) = 2 zgzafkgmwe (jxaznrifkc )
Positive
28 May 2021
Phase 2
24
(meiynjkpzb) = 6 treatment-related SAEs were reported in 5 patients (anaphylactic reaction, pyrexia, and respiratory depression) xncppudlan (kpioyznvpk )
Positive
25 May 2020
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Regulation

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