Site Editor

Leo I. Gordon, MD, FACP

Advertisement
Advertisement

FDA Brief: Epcoritamab Granted Orphan Drug Designation in Follicular Lymphoma

By: Lauren Velentzas
Posted: Friday, March 25, 2022

The U.S. Food and Drug Administration (FDA) recently granted Orphan Drug designation to epcoritamab, an investigational IgG1-bispecific antibody being co-developed by Genmab and AbbVie for patients with follicular lymphoma. Although follicular lymphoma is an indolent lymphoma, there is a need for additional treatment options, since relapsed or refractory disease is incurable with conventional therapy.

Epcoritamab is currently being evaluated as a treatment option for patients with follicular lymphoma in several clinical trials, including the phase I/II EPCORE NHL-1. The trial is evaluating the efficacy and safety of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma (ClinicalTrials.gov identifier NCT03625037).


By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.