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 follicular lymphoma (FL).

The drug is an investigational immunoglobulin G1-bispecific antibody that was created with Genmab’s DuoBody-CD3 technology, which is designed to selectively direct cytotoxic T cells to tumors to produce an immune response toward malignant cells. Epcoritamab is designed to simultaneously attach to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of lymphoma B cells, according to Genmab.

“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 between 20% and 30% of all NHL cases. FL is the second most common form of NHL and accounts for approximately 25% of adult NHL cases. FL is typically incurable, but is instead more of a chronic disease that patients can live with for many years.

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 (NCT: 03625037).

Epcoritamab is also being analyzed in a phase 1/2 trial evaluating its safety and efficacy in Japanese patients with relapsed/refractory B-NHL (NCT: 04542824).

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 (NCT: 04663347).

At the at the 63rd ASH Annual Meeting in 2021, data were presented from EPCORE NHL-2 combining subcutaneous epcoritamab with rituximab and lenalidomide (R2) in patients with relapsed or refractory FL. In that trial, 29 adults with relapsed/refractory FL were administered subcutaneous epcoritamab plus standard R2 for 12 cycles of 28 days, followed by epcoritamab monotherapy, for a total of 2 years.

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.


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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