EPKINLY (epcoritamab-bysp)
EPKINLY is indicated for the treatment of Diffuse Large B-Cell Lymphoma; High-Grade B-Cell Lymphoma; Follicular Lymphoma.
How EPKINLY Works
Epcoritamab-bysp is a bispecific antibody designed to simultaneously bind to the CD3 receptor on T-cells and the CD20 antigen expressed on lymphoma cells and healthy B-lineage cells. This dual binding activates T-cells and triggers the release of proinflammatory cytokines, which induces the lysis of B-cells. When administered in combination with rituximab, the drug facilitates both T-cell mediated cytotoxicity and natural killer cell mediated antibody-dependent cellular cytotoxicity. By bridging these immune cells, the drug directs the patient's own immune system to target and eliminate malignant B-cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-05-19
- Patent Cliff
- 2031
- Revenue
- $83M (Q1-2026)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
EPKINLY Approval History
What EPKINLY Treats
3 indicationsEPKINLY is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diffuse Large B-Cell Lymphoma
- High-Grade B-Cell Lymphoma
- Follicular Lymphoma
EPKINLY Boxed Warning
CYTOKINE RELEASE SYNDROME AND IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.1) ] . Immune Effector Cell-Associat...
WARNING: CYTOKINE RELEASE SYNDROME AND IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.1) ] . Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.2) ] . WARNING: CYTOKINE RELEASE SYNDROME and IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.6 , 5.1 ) Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.6 , 5.2 )
EPKINLY Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
EPKINLY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in EPKINLY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EPKINLY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to EPKINLY
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
50 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06191744 EPCORE™FL-2 | M22-003 2023-506906-38-00 | Ph 3 | recruiting | Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma |
| NCT05852717 | HCRN LYM22-565 | Ph 2 | recruiting | Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma |
| NCT05283720 | M22-132 2023-505347-38, 2023-505347-38-00 | Ph 2 | recruiting | A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma |
| NCT06045247 | 2023-0031 NCI-2023-07174 | Ph 2 | recruiting | Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma |
| NCT07082868 | 25-032 | Ph 1 | recruiting | A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL) |
| NCT05660967 EPCORE DLBCL-3 | GCT3013-06 2021-005744-29, jRCT2021230015 | Ph 2 | active not recruiting | Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma |
| NCT06112847 | 22509 NCI-2023-08814, 22509 | Ph 2 | active not recruiting | Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma |
| NCT07226752 | GCT3013-05 Sub-study CTR20221558 | Ph 3 | active not recruiting | A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China |
| NCT04663347 EPCORE™ NHL-2 | GCT3013-02 2023-504805-35-00, 2020-000845-15 | Ph 1, Ph 2 | active not recruiting | Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) |
| NCT04623541 EPCORE™ CLL-1 | GCT3013-03 2020-000848-57, NL74221.056.20 | Ph 1, Ph 2 | active not recruiting | Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome |
| NCT03625037 EPCORE™ NHL-1 | GCT3013-01 2017-001748-36, NL64317.078.17 | Ph 1, Ph 2 | active not recruiting | First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma |
| NCT04628494 EPCORE DLBCL-1 | GCT3013-05 2023-504830-23-00, 2020-003016-27 | Ph 3 | active not recruiting | A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) |
| NCT04542824 EPCORE™ NHL-3 | GCT3013-04 JapicCTI-205408, jRCT2080225312 | Ph 1, Ph 2 | active not recruiting | Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL) |
| NCT05848765 REFRACT | RG_22-020 | Ph 2 | recruiting | Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy |
| NCT07365306 | 25247 NCI-2025-09718, 25247 | Ph 2 | recruiting | Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT07097363 | RG1125011 NCI-2025-04889, 20955 | Ph 2 | recruiting | Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma |
| NCT07528352 REBEL | HCI198128 | Ph 1 | not yet recruiting | External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL |
| NCT06508658 EPCORE DLBCL-4 | M22-128 2024-510965-41 | Ph 3 | active not recruiting | A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT07030699 ECLAT | 25-070 | Ph 2 | withdrawn | A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma |
| NCT07451652 | HE26-00003 | Ph 2 | recruiting | Low Dose Epcoritamab Plus GemOx in R/R DLBCL |
| NCT06931652 E-REVRI | e-REVRI | Ph 2 | recruiting | Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab |
| NCT06510491 | 24-121 | Ph 2 | recruiting | Epcoritamab in Previously Treated WM |
| NCT06510361 | 24-065 | Ph 2 | recruiting | Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy |
| NCT07218510 | 24230 NCI-2025-07205, 24230 | Ph 2 | recruiting | Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial |
| NCT06919939 EPCOR+LONCA | 20241140 | Ph 2 | recruiting | Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma |
| NCT06811272 | 25-006 | Ph 2 | recruiting | Outpatient Epcoritamab as 2L in NTE R/R DLBCL |
| NCT06536049 | OSU-23364 NCI-2024-05519 | Ph 1, Ph 2 | recruiting | Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma |
| NCT06563596 | 24-393 | Ph 2 | recruiting | Epco, Zanu, Ritux for R/R FL or MZL |
| NCT06676033 | 10001671 001671-H | Ph 1 | active not recruiting | Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome |
| NCT06723457 | NU 24H07 NCI-2024-09812, STU00222751 | Ph 2 | active not recruiting | Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma |
| NCT06575686 | 23820 NCI-2024-06708, 23820 | Ph 2 | suspended | Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma |
| NCT07108998 | UCCC-HEM-24-01 IST-EPCO-00035 | Ph 2 | recruiting | Study of Epcoritamab as a Consolidation Therapy in CLL/SLL |
| NCT05783609 | 22-702 | Ph 2 | recruiting | Epcoritamab and Rituximab for First-line Follicular Lymphoma |
| NCT06796998 | 20240621 NCI-2025-06276 | Ph 2 | recruiting | Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL) |
| NCT06905509 | UCDCC316 NCI-2025-01557, UCDCC316 | Ph 2 | recruiting | Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma |
| NCT06672705 | OSU-23408 NCI-2024-08887 | Ph 1 | recruiting | Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders |
| NCT07126236 REPIFIR | REPIFIR-AGR-GEL-23 2024-514440-86-00 | Ph 2 | recruiting | Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma |
| NCT05409066 EPCORE FL-1 | M20-638 2023-505628-67 | Ph 3 | active not recruiting | Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma |
| NCT06414148 EpLCART | 22/012 | Ph 2 | recruiting | MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma |
| NCT06447376 | CASE1424 | Ph 1 | recruiting | Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab |
| NCT05206357 | M20-429 2021-004555-16 | Ph 1 | active not recruiting | Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab |
| NCT06458439 | UPCC 03424 IRB#855865 | Ph 2 | recruiting | Epcoritamab-CAR T Cells for Large B-cell Lymphomas |
| NCT05451810 | M23-362 | Ph 2 | active not recruiting | A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma |
| NCT05578976 EPCORE DLBCL-2 | M20-621 2023-505277-32 | Ph 3 | active not recruiting | A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT05201248 | M21-103 | Ph 1, Ph 2 | active not recruiting | A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma |
| NCT04358458 results posted | GCT3009-01 2019-002752-16, NL72025.056.20 | Ph 1, Ph 2 | terminated | First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas |
| NCT06238648 | ACCRU-LY-2201 NCI-2023-10170, ACCRU-LY-2201 | Ph 2 | recruiting | Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy |
| NCT06287398 | NHL38 | Ph 2 | recruiting | Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL |
| NCT05791409 AETHER | HO165 CLL | Ph 1, Ph 2 | recruiting | Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL |
| NCT07588698 | 252526 | Ph 2 | not yet recruiting | Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EPKINLY FDA Label Details
Indications & Usage
FDA Label (PDF)EPKINLY is indicated for the treatment of Diffuse Large B-Cell Lymphoma; High-Grade B-Cell Lymphoma; Follicular Lymphoma.
WARNING: CYTOKINE RELEASE SYNDROME AND IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severi...
Pro Intelligence Preview
Deep insights for EPKINLY
Revenue Insights
- • Q1-2026: $83M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • 61 total trials
- • Stage: Growth
Competitive Landscape
- • 12 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment