The US Food and Drug Administration (FDA) has granted priority review to the biologics license application (BLA) for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma (LBCL).

Epcoritamab is an IgG1-bispecific antibody designed to bind to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells. The BLA is supported by data from the LBCL cohort of the phase 2 EPCORE NHL-1 trial ( Identifier: NCT03625037), which was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma.

Results showed an overall response rate (ORR) of 63% and a complete response (CR) rate of 39% among patients who had previously received at least 2 prior lines of systemic anti-lymphoma therapy. Among patients who were naive to treatment with chimeric antigen receptor (CAR) T cells, the ORR was 69% and the CR rate was 42%. For patients previously treated with CAR T-cell therapy, the ORR was 54% and the CR rate was 34%.

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At a median follow-up of 10.7 months, the median duration of response (mDOR) was approximately 12 months. The mDOR was not reached among patients who achieved a CR, with 89% still in CR at 9 months.

The most common treatment-emergent adverse events (TEAEs) of any grade were cytokine release syndrome, pyrexia, fatigue, neutropenia, diarrhea, injection site reaction, nausea, and anemia. The most common grade 3 or 4 TEAEs included neutropenia, anemia, decreased neutrophil count, and thrombocytopenia. 

A prescription drug user fee act target date of May 21, 2023, has been set for the application.


  1. 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 A/S. Accessed November 21, 2022.
  2. Genmab announces late-breaking phase 2 trial results of investigational epcoritamab (DuoBody®-CD3xCD20) in relapsed/refractory large b-cell lymphoma (LBCL) patients presented at European Hematology Association (EHA) Presidential Symposium. News release. Genmab A/S. June 11, 2022. Accessed November 21, 2022.

This article originally appeared on MPR