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European Commission approves epcoritamab with lenalidomide and rituximab for follicular lymphoma

16 min read

The European Commission granted marketing authorization for epcoritamab (Tepkinly) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma, based on Phase 3 EPCORE FL-1 data. In the randomized trial (n=243 combination, n=245 control) the combination reduced risk of progression or death by 79% (HR 0.21), produced a 96% overall response rate and 74% complete response rate versus 81% ORR and 43% CR with lenalidomide and rituximab alone. The approval establishes a chemotherapy-free, bispecific-based second-line option in Europe while safety signals included serious adverse reactions in 44% of combination-treated patients.

The EC approved epcoritamab with lenalidomide and rituximab for R/R follicular lymphoma.

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