
FDA Grants Orphan Drug Designation to Epcoritamab for Follicular Lymphoma
Epcoritamab is an investigational immunoglobulin G1-bispecific antibody being evaluated as a treatment for patients with follicular lymphoma in multiple clinical trials.
The FDA has granted orphan drug designation to epcoritamab (DuoBody®-CD3xCD20; Genmab and AbbVie) for the treatment of
The drug is an investigational
“This orphan drug designation is an important milestone for epcoritamab,” said Jan van de Winkel, PhD, chief executive officer of Genmab, in a press release. “With AbbVie, we remain committed to further developing epcoritamab in this patient population, as well as in patients diagnosed with other B-cell hematologic malignancies.”
FL is generally a slow growing or indolent form of non-Hodgkin lymphoma (NHL) that accounts for
Approximately 2.7 per 100,000 people in the United States are diagnosed with FL annually, at a median age of 63 years. Although the disease is an indolent lymphoma, patients with FL who relapse or become refractory are incurable with conventional therapy, which highlights the need for additional treatment options.
Epcoritamab is currently being evaluated as a treatment for patients with FL in multiple clinical trials, including EPCORE™ NHL-1. The phase 1/2 trial is analyzing the efficacy and safety of subcutaneous epcoritamab in patients with relapsed or refractory B-cell NHL (B-NHL), including diffuse large B-cell lymphoma (DLBCL), FL, and mantle cell lymphoma (
Epcoritamab is also being analyzed in a phase 1/2 trial evaluating its safety and efficacy in Japanese patients with relapsed/refractory B-NHL (
Additionally, epcoritamab is being evaluated in patients with FL in the phase 1b/2, open-label, multinational, interventional EPCORE NHL-2 trial, which is analyzing the safety and preliminary efficacy of the drug in combination with other standard of care agents across multiple lines of therapy in patients with DLBCL or FL (
At the at the 63rd
Preliminary data showed a manageable safety profile and response was seen in 100% of patients, with nearly all achieving early complete metabolic response and no observed relapses.
Reference
Genmab Announces U.S. Food and Drug Administration Granted Orphan-Drug Designation to Epcoritamab (DuoBody®-CD3xCD20) in Follicular Lymphoma. [News release]. Genmab. March 8, 2022. https://www.businesswire.com/news/home/20220304005559/en/Genmab-Announces-U.S.-Food-and-Drug-Administration-Granted-Orphan-Drug-Designation-to-Epcoritamab-DuoBody%C2%AE-CD3xCD20-in-Follicular-Lymphoma.
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