The US Food and Drug Administration (FDA) granted second approval for epcoritamab (EPKINLY®) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of prior therapy, according to a press release from AbbVie, the manufacturer of the drug.
The T-cell engaging bispecific antibody was approved under the FDA’s Accelerated Approval program based on results from the phase I/II EPCORE® NHL-1 trial. Epcoritamab achieved an overall response rate of 82%, a complete response rate of 60%, and a partial response rate of 22%.
At a target dose of 48 mg, the most common adverse events included injection site reactions, cytokine release syndrome, COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, fever, cough, and headache.
Epcoritamab also received accelerated approval for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in May 2023.
“Patients with relapsed or refractory [FL] face significant treatment challenges, and there is currently no clear standard of care treatment available across practice settings,” said Jeff Sharman, MD, Disease Chair of Hematology Research at the Sarah Cannon Research Institute at Willamette Valley Cancer Institute, in the press release. “The responses observed in the [FL] cohort of the EPCORE NHL-1 clinical trial, as well as in patients with relapsed or refractory DLBCL from the trial, show the potential of [epcoritamab] to serve as an important treatment option for these patients.”