AbbVie Secures FDA Approval For EPKINLY + R2, The Only Bispecific Antibody Combination Therapy Available For Patients With Relapsed Or Refractory Follicular Lymphoma After At Least One Line Of Systemic Therapy

Author: Benzinga Newsdesk | November 18, 2025 12:51pm

-   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 R2 with 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

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.

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