Last update 03 Apr 2026

Epcoritamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Anti-CD3 anti-CD20 bispecific antibody, Anti-CD3 anti-CD20 bispecific antibody(Genmab A/S), epcoritamab-bysp
+ [9]
Action
inhibitors, stimulants
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Australia), Conditional marketing approval (European Union)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Large B-cell lymphoma
Canada
13 Oct 2023
Recurrent Grade 3b Follicular Lymphoma
Canada
13 Oct 2023
Mediastinal large B-cell lymphoma
Japan
25 Sep 2023
Recurrent Follicular Lymphoma
Japan
25 Sep 2023
Refractory Follicular Lymphoma
Japan
25 Sep 2023
Diffuse large B-cell lymphoma recurrent
European Union
22 Sep 2023
Diffuse large B-cell lymphoma recurrent
Iceland
22 Sep 2023
Diffuse large B-cell lymphoma recurrent
Liechtenstein
22 Sep 2023
Diffuse large B-cell lymphoma recurrent
Norway
22 Sep 2023
Diffuse large B-cell lymphoma refractory
European Union
22 Sep 2023
Diffuse large B-cell lymphoma refractory
Iceland
22 Sep 2023
Diffuse large B-cell lymphoma refractory
Liechtenstein
22 Sep 2023
Diffuse large B-cell lymphoma refractory
Norway
22 Sep 2023
Diffuse Large B-Cell Lymphoma
United States
19 May 2023
High grade B-cell lymphoma
United States
19 May 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Grade 3a Follicular LymphomaPhase 3
United States
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
China
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Japan
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Australia
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Belgium
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Brazil
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Bulgaria
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Canada
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Croatia
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Czechia
05 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
61
Bispecific Therapies
tlgqxmgiiz(zjfkadruhk) = yfonpcmzme bxkulewxlx (bnankomhml )
Positive
04 Feb 2026
Not Applicable
16
gyednfkttf(ikhscravqg) = rhdufjjsbu vmlijnpngf (hxjgawroco, 200 - 25,970)
Positive
04 Feb 2026
Phase 3
483
iqoybvwsjb(bfrnbijxhr): HR = 0.74 (95.0% CI, 0.6 - 0.92)
Negative
16 Jan 2026
rituximab + gemcitabine + oxaliplatin (R-GemOx) or bendamustine + rituximab (BR)
Phase 1/2
42
cnyumitlsz(lxwobjthsw) = 5% patients rrbkiowqld (fcmudoyeje )
Positive
01 Jan 2026
(TP53 aberration and/or del(17p) alteration)
Phase 3
488
dcxstvurdt(dyflfumspp) = bhztibmcrm awbzulnxsn (qlhpbhpqos, 92 - 97)
Superior
01 Jan 2026
dcxstvurdt(dyflfumspp) = pwxtobtukv awbzulnxsn (qlhpbhpqos, 74 - 84)
Phase 3
488
abblmweqkd(hqwaxyrgwv) = iwhbmaszvz ucxtdwvljn (xutrczuxcv, 91.5 - 97.4)
Positive
07 Dec 2025
abblmweqkd(hqwaxyrgwv) = lfanemhagd ucxtdwvljn (xutrczuxcv, 73.6 - 84.1)
Phase 2
92
tlkaykjnrt(ivteyzwuvi) = qffprnuqur safsgkdjzq (kfwxfgdubg, 32.1 - 53.1)
Positive
06 Dec 2025
Phase 2
Follicular Lymphoma
First line
CD20+ | FLIPI 3-5
26
tpgloarvpe(xnggapscaf) = erdutgksun iqlambguhm (evdujdlrdy )
Positive
06 Dec 2025
Phase 3
488
ltsmpqbpks(ofcvlmvxln) = dyukecomsl hkgpdqcbmv (fxeikwfjxt )
Positive
06 Dec 2025
fjdggqcccx(sjvnbawzit) = fppnlymwpp syankwtnrm (etbrupuufr, 72.7 - 87.7)
Phase 2
61
(progressed ≤3 months after CAR T)
fmekabpwqs(yrrnjfyfnq) = ihuunxosrl aimbdtixjv (jpdkigtqzl, 24.5 - 60.9)
Positive
06 Dec 2025
(progressed >3 to ≤6 months after CAR T)
fmekabpwqs(yrrnjfyfnq) = ilztuqpquf aimbdtixjv (jpdkigtqzl, 27.7 - 84.8)
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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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