Overview
- The FDA granted traditional approval to epcoritamab-bysp as a single agent after at least two prior lines of therapy and cleared its use with rituximab and lenalidomide in relapsed or refractory follicular lymphoma.
- In the randomized EPCORE FL-1 trial (n=488), epcoritamab plus rituximab and lenalidomide cut the risk of progression or death by 79% versus R2 alone (hazard ratio 0.21).
- The combination achieved an overall response rate of 89% compared with 74% for control, and median progression-free survival was not reached versus 11.2 months with R2.
- The label carries boxed warnings for cytokine release syndrome and ICANS, with CRS in 24% and ICANS in 0.8% of patients, and reports of serious adverse reactions in 51% including 28% with serious infections.
- Dosing includes a step-up schedule for monotherapy and a fixed-duration subcutaneous regimen for up to 12 cycles with R2, and additional EPCORE FL-1 results are planned for presentation at the 2025 ASH Annual Meeting.