EC approves epcoritamab in combination with lenalidomide + rituximab for R/R FL

On July 6, 2026, the European Commission (EC) approved epcoritamab in combination with lenalidomide + rituximab (R²) for the treatment of adult patients with relapsed/refractory (R/R) follicular lymphoma (FL).¹

This approval was based on results from the phase III EPCORE FL-1 trial (NCT05409066) evaluating the efficacy and safety of fixed-duration epcoritamab + R² vs R² in 488 patients with R/R FL.^1,2 At a median follow-up of 14.8 months, the overall response rate was 95% (95% confidence interval [CI], 92–97) with epcoritamab + R² vs 79% (95% CI, 74–84) with R² alone (p < 0.0001), with complete responses in 83% vs 50% of patients (p < 0.0001).² The median progression-free survival was not reached with epcoritamab + R² vs 11.7 months with R² alone, with a 79% reduction in the risk of disease progression or death in the epcoritamab + R² group (hazard ratio, 0.21; 95% CI, 0.14–0.31; p < 0.0001).² Grade ≥3 adverse events occurred in 90% of patients receiving epcoritamab + R² vs 68% of patients receiving R² alone.² Grade ≥3 adverse events of special interest included infections (33% in the epcoritamab + R² group vs 16% in the R² alone group), neutropenia (69% vs 42%), anemia (8% vs 5%), thrombocytopenia (9% vs 6%), pyrexia (<1% vs 1%), rash (8% vs 4%), and COVID-19 (3% vs 2%).²