FDA Approves Epcoritamab-bysp for Follicular Lymphoma Indications

On November 18, 2025, the FDA approved epcoritamab-bysp (Epkinly) in combination with lenalidomide and rituximab (R2) for relapsed or refractory follicular lymphoma (FL). In addition, the FDA granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL following 2 or more lines of systemic therapy, upgrading its 2024 accelerated approval for this indication.¹

The approval of epcoritamab-bysp with R2 was supported by the EPCORE FL-1 trial (NCT05409066), a randomized, open-label study with 488 patients with relapsed or refractory FL. Patients were randomized to receive epcoritamab-bysp with R2 or R2 alone. The epcoritamab-bysp arm showed superior efficacy in progression-free survival (PFS) and overall response rate. The hazard ratio was 0.21 (95% CI, 0.13-0.33; P<.0001). Median PFS was not reached (NR) (95% CI, 21.9 months, NR) in the epcoritamab-bysp arm versus 11.2 months in the R2 arm. The overall response rate was 89% in the epcoritamab-bysp arm compared with 74% in the R2 arm.

Boxed warnings include cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome. Serious adverse reactions occurred in 51% of patients, with CRS in 24% (12% serious). The recommended dosage involves a step-up schedule in cycle 1 followed by weekly and monthly dosing cycles for up to 12 cycles.

Reference

1. US Food and Drug Administration. FDA approves epcoritamab-bysp for follicular lymphoma indications. November 18, 2025. Accessed November 30, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications