The U.S. Food and Drug Administration (FDA) approved epcoritamab-bysp for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in adults after two or more prior lines of therapy. This marks the second approval for the treatment.
Epcoritamab-bysp is a subcutaneous T-cell–engaging bispecific antibody and was approved under the FDA’s Accelerated Approval program. Approval was based on the results of a phase I/II study which found an overall response rate of 82%.
Common adverse reactions seen in the study included fever, fatigue, cytokine release syndrome, diarrhea, rash, musculoskeletal pain, cough, headache, upper respiratory tract infection, COVID-19, and injection site reactions.
“[Epcoritamab-bysp] treatment has shown deep and durable responses for many patients. Subcutaneous dosing offers convenience, and [epcoritamab-bysp] can be given to patients without mandatory hospitalization using a three-step-up dosing regimen,” said Mariana Cota Stirner, MD, PhD, vice president and therapeutic area head for hematology at AbbVie. “We believe that [epcoritamab-bysp] has the potential to be a core therapy in the treatment of multiple B-cell malignancies.”
Continued approval is contingent on confirmatory trials.
Source: PR Newswire, June 26, 2024.
