AbbVie announces FDA approval of Epkinly in combo with rituximab, lenalidomide

AbbVie (ABBV) announced that EPKINLY, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab and lenalidomide is approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory follicular lymphoma. This approval of EPKINLY is 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 demonstrates the potential of this combination therapy to reshape FL treatment and to reach patients earlier in their treatment. “Recurrent follicular lymphoma can be an incurable, complex and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey,” said Lorenzo Falchi, M.D., lymphoma specialist, department of medicine, Memorial Sloan Kettering Cancer Center. “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.”