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AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma
AbbVie (NYSE: ABBV) today announced that EPKINLY® (epcoritamab-bysp), a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab and lenalidomide (EPKINLY + R2) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). 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 st
About this update from Abbvie Inc.
[{"type":"text","content":"- EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy- In the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2with approximately 3 out of 4 patients achieving a complete response- Approval marks third indication for EPKINLY and first-ever FDA approval for a bispecific combination therapy in lymphoma","length":604,"tagName":"p"},{"type":"text","content":"NORTH CHICAGO, Ill., Nov. 18, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that EPKINLY® (epcoritamab-bysp), a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab and lenalidomide (EPKINLY + R2) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). 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.i","length":712,"tagName":"p"},{"type":"text","content":""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."","length":681,"tagName":"p"},{"type":"text","content":"FL is typically an indolent (slow-growing) form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes and impacts approximately 15,000 new patients per year in the U.S.ii,iii The disease is considered...