AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma [Yahoo! Finance]
AbbVie Inc. (ABBV)
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Source: Yahoo! Finance
patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy In the Phase 3 EPCORE ® FL-1 trial, EPKINLY + R demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R 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 + R ) 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 + R c
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