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Epcoritamab in combination with rituximab + lenalidomide approved by the FDA for patients with R/R FL

By Dylan Barrett

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Nov 19, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in R/R FL.


On November 18, 2025, the U.S. Food and Drug Administration (FDA) approved epcoritamab, a T-cell engaging bispecific antibody, in combination with rituximab + lenalidomide for the treatment of adult patients with relapsed/refractory (R/R) follicular lymphoma (FL).1 This approval is based on results from the open-label, phase III EPCORE FL-1 (NCT05409066) trial, following previous accelerated approval by the FDA for epcoritamab monotherapy for the treatment of R/R FL after ≥2 prior lines of systemic therapy.1

EPCORE FL-11

  • Results from the EPCORE FL-1 trial showed that epcoritamab + rituximab + lenalidomide (n = 243) reduced the risk of disease progression or death by 79% (hazard ratio [HR], 0.21; 95% confidence interval [CI], 0.13–0.33; p < 0.0001) compared with rituximab + lenalidomide (n = 245).
  • The median progression-free survival was not reached with epcoritamab + rituximab + lenalidomide vs 11.2 months with rituximab + lenalidomide.
  • The overall response rate was 89% and 74%, and the complete response rate was 74% and 43% in the epcoritamab- + rituximab + lenalidomide and rituximab + lenalidomide arms, respectively.
  • The safety profile of epcoritamab + rituximab + lenalidomide was consistent with the known safety profile of the individual agents.

Data from the EPCORE FL-1 trial will be presented at the upcoming 67th American Society of Hematology (ASH) Meeting and Exposition, December 6–9, 2025, Orlando, US.

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