• Source: Epcoritamab

Epcoritamab, sold under the brand name Epkinly, is a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma. Epcoritamab is a bispecific CD20-directed CD3 T-cell engager. Epcoritamab was co-developed by AbbVie and Genmab.
Epcoritamab was approved for medical use in the United States in May 2023, in the European Union in September 2023, and in Canada in December 2023.




Medical uses


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.




Side effects


The most common adverse reactions include cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.




History


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.
The efficacy outcome measure was overall response rate (ORR), which was 61%. Of those patients, 38% of patients achieved complete response.




Society and culture






= Legal status

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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). It was approved for medical use in the European Union in September 2023. The EMA granted orphan drug designation to epcoritamab in both February and June 2022.




= Names

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Epcoritamab is the international nonproprietary name.




References






Further reading






External links


Clinical trial number NCT03625037 for "First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE NHL-1)" at ClinicalTrials.gov

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