| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Humanized |
| Target | CD3E,CD20 |
| Clinical data | |
| Trade names | Epkinly, Tepkinly |
| Other names | GEN3013, epcoritamab-bysp |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623023 |
| License data | |
| Routes of administration | Subcutaneous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6471H9999N1735O2007S44 |
| Molar mass | 145624.95 g·mol−1 |
Epcoritamab, sold under the brand nameEpkinly, is aBi-specific T-cell engager (BiTE) used for the treatment ofdiffuse large B-cell lymphoma.[4][7] Epcoritamab is a bispecific CD20-directed CD3 T-cell engager.[4][7] Epcoritamab was co-developed byAbbVie andGenmab.[8]
Epcoritamab was approved for medical use in the United States in May 2023,[7][9][8][10][11] in the European Union in September 2023,[6] and in Canada in December 2023.[1]
Epcoritamab isindicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including diffuse large B-cell lymphoma arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.[4][7][9]
In June 2024, the USFood and Drug Administration (FDA) expanded the indication to include the treatment of adults with relapsed or refractoryfollicular lymphoma after two or more lines of systemic therapy.[12][13]
In November 2025, the FDA approved epcoritamab withlenalidomide andrituximab for relapsed or refractory follicular lymphoma.[14] The FDA also granted traditional approval to epcoritamab as monotherapy for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy (epcoritamabwas granted accelerated approval for this indication in 2024).[14]
The USprescribing information includes aboxed warning for serious or fatal cytokine release syndrome and immune effector cell-associated neurotoxicity.[12] Warnings and precautions include serious infections and cytopenias.[12]
The most common adverse reactions includecytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions,pyrexia, abdominal pain, nausea, and diarrhea.[7]
Epcoritamab was evaluated in the EPCORE NHL-1 (NCT03625037) trial in 148 participants with relapsed or refractory B-cell lymphoma after two or more lines of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy.[7]
For the treatement offollicular lymphoma, the efficacy and safety were evaluated in EPCORE NHL-1 (Study GCT3013-01; NCT03625037), an open-label, multi-cohort, multicenter, single-arm trial that included 127 participants with relapsed or refractory FL after at least two lines of systemic therapy.[12] The primary efficacy and safety were based on 127 participants who received a two step-up dosing regimen.[12] A separate dose optimization cohort of 86 participants evaluated the recommended 3-step up dosage schedule for cytokine release syndrome mitigation.[12]
The USFood and Drug Administration (FDA) granted the application for epcoritamab for follicular lymphomapriority review andbreakthrough therapy designations.[12]
Approval of epcoritamab withlenalidomide andrituximab was based on EPCORE FL-1 (study M20-638; NCT05409066), a randomized, open-label trial that enrolled 488 participants with relapsed or refractory FL.[14] Participants were randomized (1:1) to receive epcoritamab-bysp plus R2 or R2 alone.[14] Participants had a median of one prior line of systemic therapy (range: 1 to 7); 24% and 17% had two and three or more prior lines, respectively.[14]
In July 2023, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency recommended a conditional marketing authorization for epcoritamab (Tepkinly).[15] It was approved for medical use in the European Union in September 2023.[5] The EMA grantedorphan drug designation to epcoritamab in both February and June 2022.[16][17][18]
Epcoritamab is theinternational nonproprietary name.[19][20]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
