The European Commission (EC) has granted conditional marketing authorization to epcoritamab (TEPKINLY) as monotherapy for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two lines of systemic therapy. This approval was announced in press releases from AbbVie and Genmab, who are co-developing the agent.
Epcoritamab is a subcutaneous, IgG1-bispecific antibody that binds to both CD3 on T cells and CD20 on B cells, thereby directing cytotoxic T cells to target CD20+ cells. It is the first, and currently only, such agent with approval as monotherapy in the European Union, Iceland, Liechtenstein, Northern Ireland, and Norway for treating both relapsed or refractory FL and relapsed or refractory diffuse large B-cell lymphoma after at least two lines of prior systemic therapy.
Conditional authorization from the EC for epcoritamab in this setting was supported by data from the Phase 1/2 EPCORE® NHL-1 clinical trial, the results of which were published in The Lancet Haematology. In the trial, patients with relapsed or refractory FL after two or more lines of prior systemic therapy who received this agent had an overall response rate of 83%, complete response rate of 63%, and median duration of response of 21.4 months.
The most common adverse reactions with epcoritamab in the trial were cytokine release syndrome, diarrhea, fatigue, injection site reactions, musculoskeletal pain, neutropenia, pyrexia, and viral infection.
Epcoritamab is approved in the United States and Japan under the brand name EPKINLY and has also received regulatory approval for use in certain lymphomas across multiple countries.
Sources: AbbVie, August 2024; Genmab, August 2024
© 2025 Mashup Media, LLC, a Formedics Property. All Rights Reserved.