Epcoritamab

Epcoritamab-bysp is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. In vitro, epcoritamab-bysp activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.

• 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. ( 1.1 ) This indication is approved under accelerated approval based on response rate and durability of response.ICD-10: C85.90

• None. None.contraindicated

For subcutaneous injection only. ( 2.2 ) Recommended Dosage: ( 2.2 ) DLBCL and High-grade B-cell Lymphoma Cycle Cycle = 28 days Day Dose of EPKINLY Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 First full dose 48 mg 22 48 mg Cycles 2 and 3 1, 8, 15 and 22 48 mg Cycles 4 to 9 1 and 15 48 mg Cycle 10 and beyond 1 48 mg EPKINLY as Monotherapy for FL Cycle Cycle = 28 days Day Dose of EPKINLY Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 Step-up dose 3 3 mg 22 First full dose 48 mg Cycles 2 and 3 1, 8, 15 and 22 48 mg Cycles 4 to 9 1 and 15 48 mg Cycle 10 and beyond 1 48 mg EPKINLY in Combination with Lenalidomide and Rituximab for FL Cycle Cycle = 28 days Day Dose of EPKINLY Cycle 1 1 Step-up dose 1 0.16 mg 8 Step-up dose 2 0.8 mg 15 Step-up dose 3 3 mg 22 First full dose 48 mg Cycles 2 and 3 1, 8, 15, and 22 48 mg Cycles 4 to 12 1 48 mg Monitor all patients for signs and symptoms of CRS and ICANS. ( 2.1 ) For patients with DLBCL or high-grade B-cell lymphoma, assess whether hospitalization or outpatient monitoring is appropriate after administration of the Cycle 1 Day 15 dosage of 48 mg. ( 2.1 ) For patients with FL, assess whether hospitalization or outpatient monitoring is appropriate after administration of the Cycle 1 Day 22 dosage of 48 mg. ( 2.1 ) Administer premedications, post-medications, and prophylaxis as recommended. ( 2.4 , 2.5 ) Dosages of EPKINLY 0.16 mg and 0.8 mg require dilution prior to administration. ( 2.7 , 2.8 ) See Full Prescribing Information for instructions on preparation and administration.

Infections: Can cause fatal or serious infections. Monitor patients for signs or symptoms of infection, including opportunistic infections, and treat appropriately. ( 5.3 ) Cytopenias: Monitor complete blood cell counts during treatment. ( 5.4 ) Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome EPKINLY can cause CRS, including serious or fatal reactions [see Adverse Reactions (6.1) ] . Relapsed or Refractory Large B-cell Lymphoma CRS occurred in 51% (80/157) of patients with LBCL receiving EPKINLY at the recommended dosage schedule in EPCORE NHL-1, with Grade 1 CRS occurring in 37%, Grade 2 in 17%, and Grade 3 in 2.5% of patients. Recurrent CRS occurred in 31% of these patients. Most CRS events (92%) occurred during Cycle 1. In Cycle 1, CRS events occurred in 6% of patients after the 0.16 mg dose, 12% after the 0.8 mg dose, 43% after the first 48 mg dose, and 5% after the next 48 mg dose. The median time to onset of CRS from the most recent EPKINLY dose was 24 hours (range: 0 to 10 days). The median time to onset after the first 48 mg dose was 21 hours (range: 0 to 7 days). For patients with LBCL, assess whether hospitalization or outpatient monitoring for the first 48 mg dose (Cycle 1 Day 15) is appropriate based on comorbidities or other situational factors [see Dosage and Administration (2.1) ].

The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ]. Immune Effector Cell-Associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ]. Infections [see Warnings and Precautions (5.3) ]. Cytopenias [see Warnings and Precautions (5.4) ]. EPKINLY as monotherapy for LBCL or FL: The most common (≥ 20%) adverse reactions are CRS, injection site reactions, fatigue, musculoskeletal pain, fever, diarrhea, COVID-19, rash and abdominal pain. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreases in lymphocyte count, neutrophil count, hemoglobin, and platelets. ( 6.1 ) EPKINLY in combination with lenalidomide and rituximab for FL: The most common (≥ 20%) adverse reactions are rash, upper respiratory tract infections, fatigue, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreased neutrophil count, lymphocyte count, and platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action, EPKINLY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of EPKINLY in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with epcoritamab-bysp. Epcoritamab-bysp causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, epcoritamab-bysp can cause B-cell lymphocytopenia in infants exposed to epcoritamab-bysp in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, EPKINLY has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of epcoritamab-bysp in human milk, the effect on the breastfed child, or milk production.

Metabolism

Pharmacokinetic (PK) parameters were evaluated at the approved recommended dosage (48 mg) and are presented as geometric mean (CV%) unless otherwise specified. Epcoritamab-bysp area under the concentration-time curve (AUC) increased more than proportionally over a full dosage range from 1.5 to 60 mg (0.03125 to 1.25 times the approved recommended dosage).

• May 19, 2023BLABLA761324Genmab Us, Inc.

1. 1Cytokine Release Syndrome41736%
2. 2Diffuse Large B-cell Lymphoma22920%
3. 3Diffuse Large B-cell Lymphoma Refractory21819%
4. 4Pyrexia948.0%
5. 5Immune Effector Cell-associated Neurotoxicity Syndrome938.0%
6. 6Neutrophil Count Decreased484.1%
7. 7Covid-19474.0%
8. 8Platelet Count Decreased413.5%
9. 9Cytomegalovirus Infection Reactivation403.4%
10. 10Hypogammaglobulinaemia403.4%
11. 11Pneumonia342.9%
12. 12Cytomegalovirus Infection332.8%
13. 13Death322.7%
14. 14Malignant Neoplasm Progression282.4%
15. 15Sepsis242.1%

The 10 most recently updated of 56 ClinicalTrials.gov registrations naming Epcoritamab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
  Recruiting · Phase 1 · Interventional · 26 enrolled · Memorial Sloan Kettering Cancer Center
  NCT07082868updated 2026-06-11
• External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL
  Recruiting · Phase 1 · Interventional · 12 enrolled · University of Utah
  NCT07528352updated 2026-06-04
• Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
  Recruiting · Phase 1 · Phase 2 · Interventional · 38 enrolled · Yazeed Sawalha
  NCT06536049updated 2026-06-04
• First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 666 enrolled · Genmab
  NCT03625037updated 2026-06-02
• Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma
  Active not recruiting · Phase 2 · Interventional · 111 enrolled · Genmab
  NCT05660967updated 2026-06-02
• Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 543 enrolled · Genmab
  NCT04663347updated 2026-06-02
• 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
  Recruiting · Phase 2 · Interventional · 496 enrolled · Genmab
  NCT05283720updated 2026-06-02
• Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 194 enrolled · Genmab
  NCT04623541updated 2026-06-02
• 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)
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 78 enrolled · Genmab
  NCT04542824updated 2026-06-02
• 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
  Recruiting · Phase 3 · Interventional · 1,095 enrolled · Genmab
  NCT06191744updated 2026-06-02

Frequently asked questions

How does Epcoritamab work?

Epcoritamab-bysp is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and healthy B-lineage cells. In vitro, epcoritamab-bysp activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.

What is Epcoritamab used for?

According to FDA labeling, Epcoritamab carries indications including: 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. ( 1.1 ) This indication is approved under accelerated approval based on response rate and durability of response.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Epcoritamab?

Epcoritamab is classified as Other monoclonal antibodies and antibody drug conjugates, Bispecific CD20-directed CD3 T Cell Engager, CD20-directed Antibody Interactions, CD3-directed Antibody Interactions, CD3 Receptor Agonists, Cytochrome P450 Inhibitors, Increased Cytokine Activity.

What are the brand names for Epcoritamab?

Epcoritamab is marketed under brand names including Epkinly.

What are the contraindications for Epcoritamab?

Epcoritamab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.