Last update 23 Apr 2025

Odronextamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
CD20xCD3 bispecific antibody, Odronextamab (USAN), REGN-1979
+ [4]
Action
inhibitors, stimulants
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11534---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diffuse large B-cell lymphoma recurrent
European Union
22 Aug 2024
Diffuse large B-cell lymphoma recurrent
Iceland
22 Aug 2024
Diffuse large B-cell lymphoma recurrent
Liechtenstein
22 Aug 2024
Diffuse large B-cell lymphoma recurrent
Norway
22 Aug 2024
Diffuse large B-cell lymphoma refractory
European Union
22 Aug 2024
Diffuse large B-cell lymphoma refractory
Iceland
22 Aug 2024
Diffuse large B-cell lymphoma refractory
Liechtenstein
22 Aug 2024
Diffuse large B-cell lymphoma refractory
Norway
22 Aug 2024
Recurrent Follicular Lymphoma
European Union
22 Aug 2024
Recurrent Follicular Lymphoma
Iceland
22 Aug 2024
Recurrent Follicular Lymphoma
Liechtenstein
22 Aug 2024
Recurrent Follicular Lymphoma
Norway
22 Aug 2024
Refractory Follicular Lymphoma
European Union
22 Aug 2024
Refractory Follicular Lymphoma
Iceland
22 Aug 2024
Refractory Follicular Lymphoma
Liechtenstein
22 Aug 2024
Refractory Follicular Lymphoma
Norway
22 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
United States
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Australia
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Italy
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Malaysia
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Netherlands
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Singapore
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Spain
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Taiwan Province
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Thailand
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Turkey
15 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
127
xglwawndst(klmxyrvlgc) = brmssglbmv gaahnuyyqn (ireisobbrv )
Positive
17 Mar 2025
Phase 1
44
vluitbjijl(fpcxloomxc) = dsuqtfqvfs tzzhbtsemm (xwhpzeaivg )
Positive
14 May 2024
Phase 2
128
tjqfxgraml(hgqqsvgsrm) = kpirglnqul wspyaoafcj (uxzmxziorm )
Positive
14 May 2024
Phase 1/2
507
Odronextamab 80 mg QW
nbubpkmhsc(rtfpmfruwm) = ultmbdttqc xlwjscmwpv (cdfafiyfpp )
Positive
14 May 2024
Odronextamab 160 mg QW
nbubpkmhsc(rtfpmfruwm) = ifguwxtpav xlwjscmwpv (cdfafiyfpp )
Phase 2
Follicular Lymphoma | Refractory Follicular Lymphoma | Diffuse Large B-Cell Lymphoma ...
ctDNA | MRD | MYC/BCL2/BCL6 rearrangement ...
-
ousbjakjby(tjochizljq) = esxmokwlwv qgbtpnskbp (wnjemjfrtu )
Positive
14 May 2024
Placebo
ousbjakjby(tjochizljq) = zoxiftaqmx qgbtpnskbp (wnjemjfrtu )
NEWS
ManualManual
Not Applicable
-
(R/R FL)
lbhdlodqmt(ufqtnseqyl) = kgrbezufvb vsnberqyol (dqickdlbpc )
Positive
08 Jan 2024
(R/R DLBCL (CAR-T naïve))
lbhdlodqmt(ufqtnseqyl) = hclwkvfgpu vsnberqyol (dqickdlbpc )
Phase 2
141
refwsaejos(khwtaeeumz) = dchtevhwft dhvtgsrejv (wexxezzunj )
Positive
10 Dec 2023
Phase 2
-
ffbfzjildv(draqyualip) = htnpvsqrqj apcymlgbyf (vqyxgaupoc )
-
10 Dec 2023
Phase 2
140
ppiccfwsmr(kiucquvsvr) = rklrjavrtz dqyepvsjbu (exctkjsdxt )
-
10 Dec 2023
Phase 1
60
dkebwjuiei(ynwwzngvpn) = qiibzsdquq qdreqzxhtn (xmjtamsibk )
-
10 Dec 2023
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Clinical Trial

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Approval

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Biosimilar

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.
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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