US pharmaceutical company AbbVie (NYSE:ABBV) announced on Monday that the European Commission has granted marketing authorisation for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

This combination treatment is the first and only bispecific-based therapy approved in Europe for the treatment of R/R FL in the second-line setting, offering a chemotherapy-free option.

The marketing authorisation is supported by data from the Phase 3 EPCORE FL-1 trial, an open-label interventional trial to evaluate the safety and efficacy of TEPKINLY + R2 compared to R2 alone in patients with R/R FL.

According to AbbVie, the study demonstrated that TEPKINLY + R2 reduced the risk of disease progression or death by 79% compared to R2 alone. The overall response rate (ORR) in patients treated with TEPKINLY + R2 was 96% compared to 81% in patients treated with R2. Among patients who were treated with TEPKINLY + R2, 74% achieved a complete response (CR) compared to a 43% CR rate among patients treated with R2. The safety profile of TEPKINLY + R2 in the study was consistent with the known safety profiles of the individual regimens (epcoritamab and R2).

The pivotal Phase 3 EPCORE FL-1 trial results were published in The Lancet in January 2026.