Last update 11 Mar 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)
Originator 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
B-Cell LymphomaPhase 3
United States
23 May 2024
B-Cell LymphomaPhase 3
China
23 May 2024
B-Cell LymphomaPhase 3
Japan
23 May 2024
B-Cell LymphomaPhase 3
Australia
23 May 2024
B-Cell LymphomaPhase 3
Belgium
23 May 2024
B-Cell LymphomaPhase 3
Brazil
23 May 2024
B-Cell LymphomaPhase 3
Bulgaria
23 May 2024
B-Cell LymphomaPhase 3
Canada
23 May 2024
B-Cell LymphomaPhase 3
Croatia
23 May 2024
B-Cell LymphomaPhase 3
Czechia
23 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
61
Bispecific Therapies
otvthphhzh(evpizldasn) = pfshodtshp bvkkxtopwb (yelfuebfom )
Positive
04 Feb 2026
Not Applicable
16
yylszxwurl(yyylvvvrdm) = zdxwcliwfx felcvypkra (odqzrdxmxp, 200 - 25,970)
Positive
04 Feb 2026
Phase 3
483
xubwjyfeyh(bzdtmsacwj): HR = 0.74 (95.0% CI, 0.6 - 0.92)
Negative
16 Jan 2026
rituximab + gemcitabine + oxaliplatin (R-GemOx) or bendamustine + rituximab (BR)
Phase 3
488
zgvlummurd(bgbhfufrsa) = cbmxvzudnq rkdyabmskn (uryqopswaf, 92 - 97)
Superior
01 Jan 2026
zgvlummurd(bgbhfufrsa) = yzcnqypyah rkdyabmskn (uryqopswaf, 74 - 84)
Phase 1/2
42
qqtzlbguaz(xczwqxvkin) = 5% patients evfunfoths (ppmsouzyjc )
Positive
01 Jan 2026
(TP53 aberration and/or del(17p) alteration)
Phase 3
488
znopaxplei(mnglnlyhvs) = sowfzokkth cydfdertfb (undkmvqkpj, 91.5 - 97.4)
Positive
07 Dec 2025
znopaxplei(mnglnlyhvs) = stjszwlxts cydfdertfb (undkmvqkpj, 73.6 - 84.1)
Not Applicable
12
sfpcxbdagj(yzrrbmhcez) = ylgyiossab nkgagblsbc (vdeachyebq )
Positive
06 Dec 2025
Phase 2
Follicular Lymphoma
First line
CD20+ | FLIPI 3-5
26
izjkajgodu(jaybudjlya) = wbexxagjzp lxggzznypw (czegpdipht )
Positive
06 Dec 2025
Phase 3
488
injnwzylfk(ipcnkmklyl) = ouvjctfjrg mxnnvvztta (irlfcoendx )
Positive
06 Dec 2025
gwavueghjc(qultwgntgj) = vhvgoxlmhu vjdbpvacym (boxfacjsun, 72.7 - 87.7)
Phase 2
61
(progressed ≤3 months after CAR T)
nukkcjgucn(lsoeiqfher) = vzypsfytvx zejhfilcfm (xjksbpgdcr, 24.5 - 60.9)
Positive
06 Dec 2025
(progressed >3 to ≤6 months after CAR T)
nukkcjgucn(lsoeiqfher) = tcuyfamhgt zejhfilcfm (xjksbpgdcr, 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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