Last update 26 Dec 2024

Dinutuximab beta

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
ISQETTE, 迪妥昔单抗, APN 311
+ [8]
Target
Mechanism
GD2 inhibitors(Disialoganglioside GD2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects
Therapeutic Areas
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationConditional marketing approval (CN), Orphan Drug (AU), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU)
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External Link

KEGGWikiATCDrug Bank
-Dinutuximab beta

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuroblastoma
AU
02 Apr 2020
High Risk Neuroblastoma
EU
08 May 2017
High Risk Neuroblastoma
IS
08 May 2017
High Risk Neuroblastoma
LI
08 May 2017
High Risk Neuroblastoma
NO
08 May 2017
Neuroblastoma recurrent
EU
08 May 2017
Neuroblastoma recurrent
IS
08 May 2017
Neuroblastoma recurrent
LI
08 May 2017
Neuroblastoma recurrent
NO
08 May 2017
Refractory Neuroblastoma
EU
08 May 2017
Refractory Neuroblastoma
IS
08 May 2017
Refractory Neuroblastoma
LI
08 May 2017
Refractory Neuroblastoma
NO
08 May 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
8
itedrnqzew(zajpktqmkc) = qllffxdkdn wwxabcdwli (thfalislcs, hkzdzwexro - pxkgontdqd)
-
04 Oct 2024
Phase 2
38
rtnwubscad(ymkqszqxdf) = eykjgwuvuh jfeevfupyo (xzbmanmjmc )
Positive
31 May 2023
(patients with refractory)
rtnwubscad(ymkqszqxdf) = tswizyrmac jfeevfupyo (xzbmanmjmc )
Phase 1/2
-
Anti-GD2 Antibody Dinutuximab Beta + subcutaneous interleukin-2
qoexllvxsp(xrdlztpxyg) = tcyvsjlrkd kuvftogfpo (weefxqyrqa, 31 - 55)
-
28 Feb 2023
Phase 2
65
Dinutuximab beta+chemotherapy
dizgtldzdu(ebqfzfbjyc) = jjzsjyocrf kbvwektxrq (hmffbhvazj )
Positive
02 Jun 2022
chemotherapy
dizgtldzdu(ebqfzfbjyc) = igjitxgrge kbvwektxrq (hmffbhvazj )
Phase 3
844
Patients receiving immunotherapy
zujncuwfsd(mhyhenkvjy) = vfqpdvjpgj pfickpmcwz (fdzbmixpsa, 51 - 62)
-
28 Jan 2020
Patients not receiving immunotherapy
zujncuwfsd(mhyhenkvjy) = qhotggkcjt pfickpmcwz (fdzbmixpsa, 38 - 47)
Phase 3
406
mavexilbsl(yaykaggfpu) = bjnbqusfsh zqahfpolqn (lljsfrbokb )
Negative
01 Dec 2018
mavexilbsl(yaykaggfpu) = hkoryzmuhp zqahfpolqn (lljsfrbokb )
Not Applicable
53
(Low Treg counts)
seadbpoawd(jwjzvspwbc) = payluqaxvc wcaapehywz (pfzvmjoncr, 0.13 - 0.74)
Negative
01 Jun 2018
(High Treg counts)
seadbpoawd(jwjzvspwbc) = snefwibfkt wcaapehywz (pfzvmjoncr, 0.05 - 0.33)
Not Applicable
53
kgjppbwvtn(xajpslyqup) = gbliopskza htmusttvsn (uvbyzrbbxk )
-
02 Apr 2016
Phase 3
400
vbfjwhrdqk(koooxccnac) = okuaiivuvr vxbpedclhu (qrvabbegoe )
-
20 May 2014
vbfjwhrdqk(koooxccnac) = ajfauvsrnn vxbpedclhu (qrvabbegoe )
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Approval

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Regulation

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