By: Phillip Mcleod
The US Food and Drug Administration (FDA) will review a supplemental Biologics License Application (sBLA) for epcoritamab combined with rituximab and lenalidomide (R2) for adult patients with relapsed or refractory follicular lymphoma (FL) after at least one prior therapy.
The manufacturer of the therapy, Genmab, plans to submit the application in the first half of 2025, according to a company press release.
Epcoritamab, a bispecific antibody, showed a positive overall response rate in the phase 3 EPCORE FL-1 trial compared with R2 alone, according to Genmab. The trial’s interim results, with no new safety concerns, support the submission. Genmab plans to share complete trial findings sometime in 2025.
The safety and efficacy of epcoritamab for use as a combination thereapy has not been established. The therapy is currently approved by the FDA under Accelerated Approval as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, Genmab wrote in the release.
