AbbVie’s TEPKINLY (epcoritamab) Plus R² Granted EU Approval for Relapsed/Refractory Follicular Lymphoma

AbbVie’s TEPKINLY (epcoritamab) Plus R² Receives EU Marketing Authorization for Relapsed/Refractory Follicular Lymphoma

On July 6, 2026, AbbVie announced that the European Commission has granted marketing authorization for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R² regimen) for the treatment of adult patients with relapsed or refractory follicular lymphoma (R/R FL). This approval introduces a chemotherapy-free, fixed-duration regimen into clinical practice across the European Union.

Approval Based on Phase III EPCORE FL-1 Trial

The authorization is supported by data from the pivotal Phase III EPCORE FL-1 trial, an open-label, interventional study evaluating the efficacy and safety of TEPKINLY combined with R² versus R² alone in patients with R/R FL who had received at least one prior line of therapy. Patients were randomized 1:1 to receive either TEPKINLY plus R² (n=243) or R² alone (n=245), covering a broad range of patient characteristics and disease risk factors. TEPKINLY was administered in 28-day cycles for up to 12 cycles, or until disease progression or unacceptable toxicity.

Efficacy was assessed using dual primary endpoints: progression-free survival (PFS) and overall response rate (ORR) as determined by an independent review committee per the 2014 Lugano criteria. Secondary endpoints included complete response rate (CR) and duration of response (DOR). Results showed that TEPKINLY plus R² significantly reduced the risk of disease progression or death compared to R² alone. Full results were published in The Lancetin January 2026.

Professor Catherine Thieblemont, MD, PhD, Head of the Hematology-Oncology Department at Saint-Louis Hospital, Université Paris Cité, commented: “Follicular lymphoma is a chronic, incurable malignancy where patients often experience repeated relapses, each time with shorter remissions and fewer options. The EPCORE FL-1 results are clinically meaningful, demonstrating that TEPKINLY plus R² has the potential to change the treatment landscape and offer a durable, chemotherapy-free remission.”

Safety Profile

The safety profile of TEPKINLY plus R² was consistent with the known safety profiles of the individual agents. The most common adverse reactions included neutropenia, rash, upper respiratory tract infection, fatigue, diarrhea, injection site reaction, anemia, constipation, thrombocytopenia, cytokine release syndrome (CRS), hypogammaglobulinemia, COVID-19 infection, pyrexia, and pneumonia.

Dr. Roopal Thakkar, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, stated: “There is an urgent need for new treatment options to improve outcomes for patients with R/R FL, especially in earlier lines of therapy. This approval is a significant step forward, providing an effective new choice for patients across Europe and representing important progress in the field of follicular lymphoma.”

Dr. Mitchell Smith, MD, PhD, Chief Medical Officer of the Follicular Lymphoma Foundation, added: “After a diagnosis of FL, patients often find themselves in a relentless cycle of relapse and treatment. The approval of epcoritamab plus R² in Europe is an exciting development that brings innovative hope to the FL community.”

About Follicular Lymphoma

Follicular lymphoma is a typical indolent non-Hodgkin lymphoma arising from B lymphocytes. It is the second most common subtype of NHL, accounting for 20%–30% of all cases. Incidence is notably higher in European populations (11%–29%) compared to non-European populations (2%–18%). The disease is currently considered incurable, and there is no standard of care for third-line or later R/R FL. Even patients who achieve remission frequently relapse.

About Epcoritamab

Epcoritamab is an IgG1 bispecific antibody created using Genmab’s proprietary DuoBody® technology (DuoBody-CD3). It is administered subcutaneously and simultaneously binds to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20-positive cells.

The product is marketed as EPKINLY in the United States and Japan, and as TEPKINLY in the European Union. It is currently approved for certain lymphoma indications in more than 65 countries and regions worldwide. Epcoritamab is being co-developed by AbbVie and Genmab under their oncology collaboration, with both companies sharing commercialization responsibilities in the U.S. and Japan; AbbVie handles commercialization in the rest of the world. The partners will continue pursuing additional international regulatory submissions for R/R FL and further approvals for relapsed/refractory diffuse large B-cell lymphoma.