This marks the second indication for the bispecific CD20-directed CD3 T-cell engager. The agent was first approved in 2023 for relapsed or refractory diffuse large B-cell lymphoma in adults.
The current approval was based on the single-arm EPCORE NHL-1 trial in 127 patients with follicular lymphoma who had received at least two lines of systemic therapy.
After a two step-up dosing regimen, the overall response rate was 82%, with 60% of patients achieving a complete response. At a median follow-up of 14.8 months, the median duration of response was not reached. The 12-month duration of response was 68.4%.
Efficacy was similar in the 86 patients who received a three step-up dosing schedule.
Labeling carries a black box warning of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Adverse events in 20% or more of patients included injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.
Decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin were the most common grade 3/4 laboratory abnormalities.
Three step-up dosing is the recommended regimen, with epcoritamab administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Dosing is increased by steps to the full 48 mg in cycle 1.
The price is $16,282.52 for 48 mg/0.8 mL, according to drugs.com.
A version of this article appeared on Medscape.com.