EPKINLY
EPKINLY (epcoritamab-bysp) is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with specific types of relapsed or refractory B-cell lymphomas. It is used as a monotherapy for diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma after two or more lines of systemic therapy, an indication granted under accelerated approval. For patients with relapsed or refractory follicular lymphoma, the drug is approved for use as a monotherapy after two prior lines of therapy or in combination with lenalidomide and rituximab. This therapeutic provides a targeted treatment option for patients whose disease has progressed following multiple standard systemic treatments.
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.
Details
- Status
- Prescription
- First Approved
- 2023-05-19
- 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 Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to EPKINLY
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
ProIndications & Usage
FDA Label (PDF)EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In combination with lenalidomide an...
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.