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Leo I. Gordon, MD, FACP


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 ( identifier NCT03625037).

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