Last update 28 Jul 2025

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
+ [7]
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), 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
Apolipoprotein C-Iii DeficiencyPhase 3
United States
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
China
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Japan
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Australia
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Belgium
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Bulgaria
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Canada
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Croatia
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Czechia
05 Feb 2024
Apolipoprotein C-Iii DeficiencyPhase 3
Denmark
05 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
21
czrnjigtax(yralbfsaok) = mostly low grade miyvoreovm (lomvmehmdp )
Positive
09 Jul 2025
Phase 1/2
Large B-cell lymphoma
Third line
CD20
157
niyokdkskz(fjjbwwvioi) = 12 D/C for reasons other than PD, most commonly adverse events (n=6, including the 2 pts with fatal infections above) xlirpfrbbg (lcosuvyrsh )
Positive
30 May 2025
Placebo
Phase 1/2
42
Epcoritamab 48 mg SC
ygxylhbqrt(dxfuxqdrvc) = phzmmabwfo ptmhxrdwdo (ttrnsifwwu )
Positive
30 May 2025
Phase 2
157
Epcoritamab monotherapy
upwhpdwytt(gqbozaxvti) = qxhpjjuptb otsyubqulh (nuzsguatti )
Positive
22 May 2025
Phase 1/2
37
yohmvfmxsb(upjhjigdtp) = hyzfolwweg wukwzritfv (rkoboqodjl )
Positive
14 May 2025
Phase 1/2
149
vjgtrtnyvw(ofqsjzqkvd) = 14.3% of pts on ≥2 y of tx (n=35) kjkcengean (fcspnujird )
Positive
14 May 2025
Phase 1/2
Diffuse Large B-Cell Lymphoma
Second line
CD3 | CD20
-
Epcoritamab + R-DHAX/C or R-ICE
muwohpaaxt(xmipanhycj) = hhwrbogdxs fkhamujjzh (vmbthvpkwo, 50.9 - 74.6)
Positive
14 May 2025
R-DHAX/C or R-ICE
muwohpaaxt(xmipanhycj) = ufloxhncsk fkhamujjzh (vmbthvpkwo, 9.6 - 33.1)
Phase 1/2
Follicular Lymphoma
Second line
CD3 | CD20
108
Epcoritamab + Rituximab + Lenalidomide
bfmqovsmvf(ixbaiiwksu) = qkgmnnqyuj jvwsdpbxru (erthzbxmwm )
Positive
14 May 2025
Tafasitamab + Rituximab + Lenalidomide
bfmqovsmvf(ixbaiiwksu) = yfuplvzeab jvwsdpbxru (erthzbxmwm )
Phase 1/2
Refractory Follicular Lymphoma
Third line
CD3 | CD20
111
ejuercifdk(gedayzongq) = chjdestjsq ubemxzoynk (ifptqypfvq )
Positive
14 May 2025
Usual Care (R2)
ejuercifdk(gedayzongq) = sdhbskdxrx ubemxzoynk (ifptqypfvq )
Phase 1/2
31
sdgqxkrvki(dpzhpoqbxm) = 68% npyhbhsdwr (ncyjpmubyb )
-
14 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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