AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorization for Tepkinly (epcoritamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma.

The approval is based on results from the Phase 3 EPCORE FL-1 trial, which compared the fixed-duration Tepkinly combination regimen against lenalidomide and rituximab alone. The trial showed the combination reduced the risk of disease progression or death by 79% compared to the control arm (HR 0.21, 95% CI: 0.13–0.33, p<0.0001). The overall response rate among patients receiving the combination was 96%, compared to 81% in the control group. A complete response was achieved in 74% of patients in the combination arm, versus 43% in the control arm.

The most common adverse reactions occurring in at least 20% of patients treated with the combination included neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome, hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurred in 44% of patients.

Follicular lymphoma is a form of non-Hodgkin lymphoma accounting for 20–30% of all non-Hodgkin lymphoma cases. Incidence in European populations is reported at 11–29%, compared to 2–18% in non-European populations, according to published research cited in the press release.

Epcoritamab is co-developed by AbbVie and Genmab. It is marketed as Tepkinly in the European Union and as Epkinly in the U.S. and Japan. The drug has received regulatory approval in certain lymphoma indications in more than 65 territories. The EPCORE FL-1 trial results were published in The Lancet in January 2026.