| 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 a monoclonal antibodyanticancer medication 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]
The USFood and Drug Administration (FDA) prescribing 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]
In July 2023, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency recommended a conditional marketing authorization for epcoritamab (Tepkinly).[14] 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.[15][16][17]
Epcoritamab is theinternational nonproprietary name.[18][19]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
