The Biologics License Application (BLA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed and refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, has been accepted for priority review by the US Food and Drug Administration (FDA). 

If approved, epcoritamab would be the first subcutaneous bispecific antibody approved for treating large B-cell lymphoma. 

“We are pleased that the BLA for epcoritamab has been accepted for Priority Review by the FDA, accelerating the pathway for approval and bringing us 1 step closer to potentially delivering a novel treatment option to relapsed and refractory LBCL patients who are in need of additional treatment options,” said Jan van de Winkel, PhD, the chief executive officer of Genmab. 

Read more about DLBCL treatment

The approval is based on data from the pivotal EPCORE NHL-1 open-label, multicenter phase 2 clinical trial, which is evaluating epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin lymphoma. According to these data, epcoritamab demonstrated a manageable safety profile consistent with previous findings as well as clinically meaningful efficacy in patients with large B-cell lymphoma who are challenging to treat.

Epcoritamab is an investigational antibody created using Genmab’s proprietary DuoBody technology, which is designed to direct cytotoxic T cells to drive an immune response toward target cells. It is designed to bind to CD3 on T cells and CD20 on B cells and induces T cell-mediated killing of CD20+ B cells.

Large B-cell lymphoma is a type of non-Hodgkin lymphoma. DLBCL is a major subtype and the most common type of non-Hodgkin lymphoma. 

Epcoritamab is also being investigated as a monotherapy in a phase 3, open-label, randomized clinical trial in patients with relapsed/refractory DLBCL, and the European Medicines Agency validated a Marketing Authorization Application for review for epcoritamab for the treatment of patients with relapsed/refractory DLBCL after 2 or more lines of systemic therapy.

Reference

Genmab announces US Food and Drug Administration accepts for priority review Biologics License Application (BLA) for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma (LBCL). News release. Genmab; November 21, 2022.