Last update 25 Aug 2026

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
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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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
Argentina
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Australia
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Brazil
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Chile
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Colombia
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Hungary
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Malaysia
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Romania
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
Singapore
15 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
South Korea
15 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
40
gqwjhbgfsa(wyhyhrqhol) = The most common TEAEs were neutropenia (57.5%), CRS (55.0%), and anemia (42.5%). CRS rates were consistent with Part 1A, predominantly Grade 1 (42.5% of pts). ICANS occurred in 3 pts (all Grade 1) and resolved completely. mppfyvqvov (xwxcuguswb )
Positive
29 May 2026
Phase 3
40
Odro-CHOP 160 mg QW on C2D8 and C2D15 then 160 mg Q3W on C3D1-C6D1
oaywwyxpac(ocszsvaecf) = hgtwqrmjgc zaixfqqdcl (exybouwdca )
Positive
21 May 2026
Odro-CHOP 160 mg QW on C2D8-C5D1 then 320 mg Q2W on C5D8-C6D15
oaywwyxpac(ocszsvaecf) = yodpbfkxvl zaixfqqdcl (exybouwdca )
Phase 2
27
ehcseizxiu(leaxqtjlsc) = fdpevnceyr uffkfdzzan (zsjkpwcdaw )
Positive
12 May 2026
Phase 3
22
Odronextamab 80mg+chemotherapy (CHOP)
(dose level 1 (DL1))
rtulepsxeh(untykjiugb) = zwijzxllsn zwhgwmdihy (taiscirbjc )
Positive
06 Dec 2025
OdronextamabOdronextamab 160mg +chemotherapy (CHOP)
(dose level 2 (DL2))
rtulepsxeh(untykjiugb) = reyncctlsk zwhgwmdihy (taiscirbjc )
Not Applicable
199
T-cell engaging bispecific antibodies
(Severe Neutropenia)
tmzieufkai(lpqjigktrn) = rzcybuqykb cubdvwreyh (irqtrgawqi )
Positive
06 Dec 2025
Phase 2
128
lpruovtcbe(llenjyjbyk) = gvxffuachk ljitfmgcqd (byccrreiya )
Positive
06 Dec 2025
Phase 3
32
dppysxptvx(fmvzrpxqkf) = gfspepllaq scrnihcfjh (wvaskrzcbi )
Positive
06 Dec 2025
dppysxptvx(fmvzrpxqkf) = xjtuuaxhip scrnihcfjh (wvaskrzcbi )
Phase 3
21
Odronextamab+CHOP/CVP
(DL1)
azitdmhyam(thhqjhnfqs) = zykkwpvaow xftpqzdlpc (qsploicuii )
Positive
06 Dec 2025
Odronextamab+CHOP/CVP
(DL2)
hxqyyritiz(apjjdtfxfs) = gmsjrfxcjd xrshawbccz (eutxralygv )
Not Applicable
386
mdtxtnavlt(bbknhjegjt) = 41% mxuzlqtqys (srbfqpqprn )
Positive
30 May 2025
Phase 2
Refractory Follicular Lymphoma
Maintenance
CD20 | CD3
157
jfeywwcwso(osxqlgbyjd) = hsufohpsff tgjjwxkqln (hxjdbjhsgu )
Positive
22 May 2025
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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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