US-based pharmaceutical company AbbVie (NYSE:ABBV) announced on Tuesday that it has received approval from the US Food and Drug Administration for EPKINLY (epcoritamab-bysp), a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab and lenalidomide (EPKINLY + R2), for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

This decision was based on results from the pivotal Phase 3 EPCORE FL-1 study that evaluated fixed duration EPKINLY + R2 compared to standard of care R2 and demonstrated the potential of this combination therapy to reach patients earlier in their treatment.

FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes and impacts approximately 15,000 new patients per year in the United States. The disease is considered incurable with current available therapies. Patients with FL often relapse, and in some cases, the disease can transform into a more aggressive form of NHL called diffuse large B-cell lymphoma (DLBCL).

Highlighting the "clear need" for additional treatments, Lorenzo Falchi, MD, lymphoma specialist at the Department of Medicine, Memorial Sloan Kettering Cancer Center, said: "The results shown with EPKINLY + R2 in the EPCORE FL-1 study are incredibly meaningful, demonstrating durable responses compared to patients treated with R2 alone. These data, delivered by a regimen that's chemotherapy-free and can be administered in the outpatient setting, suggest that EPKINLY + R2 could potentially become a new standard of care."