Monoclonal antibody | |
---|---|
Type | Bi-specific T-cell engager |
Source | Humanized |
Target | CD3E, CD20 |
Clinical data | |
Trade names | Epkinly, Tepkinly |
Other names | epcoritamab-bysp, GEN3013 |
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 name Epkinly, is a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma. [4] [7] Epcoritamab is a bispecific CD20-directed CD3 T-cell engager. [4] [7] Epcoritamab was co-developed by AbbVie and Genmab. [8]
Epcoritamab was approved for medical use in the United States in May 2023, [4] [7] [9] [8] [10] [11] in the European Union in September 2023, [6] and in Canada in December 2023. [1]
Epcoritamab is indicated 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]
The most common adverse reactions include cytokine 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]
The efficacy outcome measure was overall response rate (ORR), which was 61%. Of those patients, 38% of patients achieved complete response. [7]
In July 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended a conditional marketing authorization for epcoritamab (Tepkinly). [12] It was approved for medical use in the European Union in September 2023. [5] The EMA granted orphan drug designation to epcoritamab in both February and June 2022. [13] [14] [15]
Epcoritamab is the international nonproprietary name. [16] [17]