The US Food and Drug Administration has approved epcoritamab (EPKINLY®) in combination with rituximab and lenalidomide (EPKINLY + R2) for adult patients with relapsed or refractory follicular lymphoma.
This FDA approval marks the third indication for epcoritamab, according to Genmab, the manufacturer of the drug.
The FDA approval is based on the phase 3 EPCORE FL-1 trial, a randomized, open-label trial that enrolled 488 patients with relapsed or refractory FL.The prescribing information includes boxed warnings for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, as well as warnings and precautions for infections and cytopenias, according to a press release from the FDA.
“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, MD, a lymphoma specialist at Memorial Sloan Kettering Cancer Center, in a press release from Genmab. “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.”
