FDA Approves Epcoritamab for Relapsed/Refractory DLBCL and High-Grade B-Cell Lymphoma


Patients with relapsed/refractory diffuse large B-cell lymphoma can now receive epcoritamab following the FDA’s approval of the agent.

The FDA granted approval to epcoritamab-bysp (Epkinly) as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, as well as DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma following 2 or more prior lines of therapy, according to a press release from the FDA.1

Data from the phase 1/2 EPCORE NHL-1 trial supported the FDA's approval of epcoritamab in relapsed/refractory DLBCL.

Data from the phase 1/2 EPCORE NHL-1 trial supported the FDA's approval of epcoritamab in relapsed/refractory DLBCL.

Supporting data for the FDA’s approval came from the phase 1/2 EPCORE NHL-1 trial (NCT03625037), in which investigators evaluated epcoritamab in patients with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkin lymphoma. Patients receiving epcoritamab had an overall response rate (ORR) of 61% (95% CI, 53%-69%), which included a complete response rate of 38%. Additionally, the estimated median duration of response (DOR) was 15.6 months (95% CI, 9.7-not reached) after a median follow-up of 9.8 months.

According to data from the EPCORE NHL-1 trial shared in an oral presentation at the 2022 European Hematology Association Congress Presidential Symposium, the estimated median DOR was 12 months, the median DOR for patients who achieved CR was not reached, and 89% of CRs were ongoing after 9 months.2

In the open-label, phase 1/2 EPCORE NHL-1 trial, patients received epcoritamab via subcutaneous injections as part of a 28-day cycle.

The primary end point of the phase 2 expansion portion of the trial was ORR as assessed by an independent review committee. Secondary end points included DOR, CR rate, progression-free survival, time to response, overall survival, time to next therapy, and rate of minimal residual disease negativity.

Patients 18 years and older with CD20-positive non-Hodgkin lymphoma and measurable disease were eligible for enrollment on the phase 1/2 EPCORE NHL-1 trial. Additional inclusion criteria included having an ECOG performance status of 0 to 2 and acceptable renal and liver function.

The DLBCL cohort of the phase 1/2 EPCORE NHL-1 trial included 157 patients with relapsed/refractory LBCL who received a median of 3 prior lines of therapy. Investigators reported that 61% of patients were refractory to primary treatment, 20% received prior autologous stem cell transplantation, and 39% previously received CAR T-cell therapy. Additionally, 75% of those receiving CAR T-cell therapy were refractory to CAR T.

The safety profile of epcoritamab in the trial was consistent with previous reports of the agent. The most common any-grade treatment-emergent adverse effects (TEAEs) included cytokine release syndrome (49.7%), pyrexia (23.6%), fatigue (22.9%), neutropenia (21.7%), diarrhea (20.4%), and injection site reactions (19.7%). The most common grade 3/4 TEAEs were neutropenia (14.6%), anemia (10.2%), and neutrophil count decrease (6.4%).

The FDA granted priority review to epcoritamab in relapsed/refractory LBCL after 2 or more lines of therapy in November 2022.3 Data from the LBCL cohort of the EPCORE NHL-1 trial supported the biologic license application for epcoritamab in this indication.


  1. FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma. News release. FDA. May 19, 2023. Accessed May 19, 2023. bit.ly/45j0zeg
  2. Genmab announces late-breaking phase 2 trial results of investigational epcoritamab (DuoBody®-CD3xCD20) in relapsed/refractory large B-cell lymphoma (LBCL) presented at European Hematology Association (EHA) Presidential Symposium. News release. Genmab. June 11, 2022. Accessed May 1, 2023. http://bit.ly/3EPMREh
  3. 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). News release. Genmab. November 21, 2022. Accessed May 1, 2023. http://bit.ly/3tNeMhT
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