AbbVie has secured US Food and Drug Administration (FDA) approval for EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). This marks the first bispecific antibody therapy approved for FL in the second-line and beyond.

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study, which demonstrated significantly superior outcomes for the EPKINLY + R2 combination compared to the standard R2 treatment alone.

“Recurrent follicular lymphoma can be complex and persistent, creating a clear need for treatments that can change its course earlier in therapy,” said Lorenzo Falchi, lymphoma specialist at Memorial Sloan Kettering Cancer Center. “EPKINLY + R2 delivers durable responses in a chemotherapy-free, outpatient regimen, and could become a new standard of care.”

Previously granted Breakthrough Therapy Designation, EPKINLY had received accelerated FDA approval as a monotherapy in June 2024.

With the confirmatory Phase 3 data, the FDA has now granted full approval for R/R FL, paving the way for AbbVie to pursue additional international regulatory approvals.