The FDA has granted traditional approval to epcoritamab-bysp (Epkinly) for relapsed or refractory follicular lymphoma (FL) in two settings:
In combination with Rituximab + Lenalidomide (R²) after ≥1 prior therapy, and As monotherapy after ≥2 prior treatments.
In the Phase 3 EPCORE FL-1 trial, epcoritamab + R² demonstrated a 79% reduction in the risk of progression (HR 0.21) and a high response rate (ORR 89%), establishing it as a highly effective chemo-sparing option.
Epcoritamab is a subcutaneous CD3×CD20 bispecific antibody and includes boxed warnings for CRS and ICANS, emphasizing the need for appropriate monitoring and step-up dosing.
This approval provides a meaningful new option for patients with relapsed/refractory FL and strengthens the growing role of bispecific therapies in lymphoma care.