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

On September 24, 2026, Health Canada issued a Notice of Compliance for epcoritamab, in combination with lenalidomide + rituximab (R²), for the treatment of adult patients with Grade 1, 2, or 3a relapsed/refractory (R/R) follicular lymphoma (FL) after ≥1 prior line of systemic therapy.¹

This authorization was supported by results from the phase III EPCORE FL-1 (NCT05409066) trial of epcoritamab + R² vs R² alone in patients with R/R FL after ≥1 prior line of therapy.^1,2 The overall response rate (ORR; 95% vs 79%; p < 0.0001) and complete response (CR) rate (83% vs 50%; p < 0.0001) were significantly improved with epcoritamab + R² vs R² alone.² Additionally, estimated 16-month progression-free survival (PFS) rates were significantly longer with epcoritamab + R² vs R² alone (85.5% vs 40.2%), representing a 79% reduction in risk of disease progression or death (hazard ratio [HR], 0.21; 95% confidence interval [CI], 0.13–0.33; p < 0.0001).^1,2 Treatment-related adverse events (TRAEs) of any grade occurred in 97% of patients receiving epcoritamab + R² vs 90% of patients receiving R² alone, with serious adverse events (SAEs) in 56% vs 29% of patients.²