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Drug

Epcoritamab

Approved · FDA / EMA
Late-stage development

Also known as Epkinly.

RxNorm2637392UNIID6OMY2L0WA
48
Active clinical trials
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Study of Epcoritamab and Lenalidomide (E-Len) in Patients With Previously Untreated Follicular Lymphoma (FL)

Clinical trial2026-07-17Primary completion · ClinicalTrials.gov

A Phase II Trial Evaluating Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma

Clinical trial2026-07-10Results expected Q4 2027 · ClinicalTrials.gov

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

Clinical trial2026-07-08Results expected Q4 2029 · ClinicalTrials.gov

A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory/Relapsed Immunodeficiency-Related Large B-Cell Lymphoma

Clinical trial2026-07-08Results expected Q1 2027 · ClinicalTrials.gov

Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Clinical trial2026-07-08Results expected Q3 2027 · ClinicalTrials.gov

A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Clinical trial2026-07-07Results expected Q1 2029 · ClinicalTrials.gov

A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Clinical trial2026-07-07Results expected Q3 2027 · ClinicalTrials.gov

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Clinical trial2026-07-07Results expected Q4 2027 · ClinicalTrials.gov

Label change: EPCORITAMAB-BYSP (BLA761324)

Regulatory2026-06-17FDA

Indication expansion: EPCORITAMAB-BYSP (BLA761324)

Regulatory2026-03-27FDA

Indication expansion: EPCORITAMAB-BYSP (BLA761324)

Regulatory2025-11-18FDA

Label change: EPCORITAMAB-BYSP (BLA761324)

Regulatory2025-09-11FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Epcoritamab
Aliases & brands
Epkinly
RxNorm CUI
2637392
UNII
D6OMY2L0WA
Regulatory jurisdictions
emafda

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-05-19 → 2024-06-26)
Earliest approval
2023-05-19
Latest approval
2026-03-27
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 6 events
2026-06-17Label change
Label change: EPCORITAMAB-BYSP (BLA761324)
Evidence ↗
2026-03-27Indication expansion
Indication expansion: EPCORITAMAB-BYSP (BLA761324)
Evidence ↗
2025-11-18Indication expansion
Indication expansion: EPCORITAMAB-BYSP (BLA761324)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-09-22ApprovalMulti-authority
Approval: Tepkinly (EMA)
Indication: Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic… Show full indication

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

52 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
52
registered trials across all phases
48
Active studies
33
Recruiting
6
Late-stage (III+)
4
Discontinued
PHASE DISTRIBUTIONn = 52
Phase 16Phase 1 / 29Phase 231Phase 36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

RecruitingPH IIIKey trialGenmabn=1,0952037

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

Active, not recruitingPH IIIGenmabn=5492029

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Active, not recruitingPH IIIGenmabn=9002029

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Active, not recruitingPH IIIGenmabn=722028

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Active, not recruitingPH IIIGenmabn=4832028
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.