FDA Accepts BLA for Genmab’s Epcoritamab to Treat Relapsed/Refractory LBCL


Agency’s action date is May 21, 2023, for the first subcutaneous bispecific antibody approved for the treatment of large B-cell lymphoma.

The FDA has accepted for priority review the biologics license application (BLA) for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after 2 or more lines of systemic therapy.

Epcoritamab is an investigational immunoglobulin G1-bispecific antibody created using Genmab’s proprietary DuoBody technology. The technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Further, epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T-cell-mediated killing of CD20+ cells.

LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL), which is a cancer that develops in the lymphatic system and affects B-cell lymphocytes. Additionally, diffuse large B-cell lymphoma is a fast-growing type of NHL3 and the most common type of NHL. It can show up in lymph nodes and organs outside the lymphatic system and occurs more commonly in the elderly.

The submission is based on safety and preliminary efficacy data from the LBCL cohort of the EPCORE NHL-1 (NCT03625037)open-label, phase 2 clinical trial evaluating epcoritamab in patients with progressive, relapsed, or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL).

EPCORE NHL-1 included a phase 1 first-in-human, dose escalation part; a phase 2 expansion part; and an optimization part. In the phase 2 expansion part, additional patients are treated with epcoritamab to further analyze the efficacy and safety of the treatment in patients with different types of relapsed/refractory B-NHLs who had limited therapeutic options.

The primary endpoint of the phase 2 expansion part was the overall response rate as assessed by an IRC. The secondary efficacy endpoints included complete response rate, duration of response, overall survival, progression-free survival, rate of minimal residual disease negativity, time to next therapy, and time to response.

“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,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a statement. “Together with our partner, AbbVie, we recognize the unmet need for safe, effective, and accessible treatments for patients with B-cell malignancies, and we believe that epcoritamab has the potential to become a core therapy in this patient population.”


Genmab announces U.S. 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). Genmab. November 21, 2022. Accessed November 22, 2022. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-us-food-and-drug-administration-accepts

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