On May 19, 2023, AbbVie announced that it had received approval for epcoritamab-bysp (EpkinlyTM) from the United States Food and Drug Administration (FDA) to treat adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B–cell lymphoma (HGBL), after at least 2 lines of systemic therapies.

“DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of [EpkinlyTM] represents a new treatment mechanism of action for third line DLBCL patients,” said Thomas Hudson, MD, senior vice president of research and development at AbbVie. 

Read more about DLBCL therapies

Epcoritamab-bysp is an IgG1-bispecific antibody used to treat individuals with certain types of DLBCL and HGBL who relapsed over time or did not respond to previous treatment and have received 2 or more treatments for their cancer. It is codeveloped by AbbVie in association with Genmab as part of the company’s oncology collaboration. It has been approved under the FDA’s Accelerated Approval program based on the response rate and durability of the response.

The phase 1/2 EPCORE NHL-1 clinical trial conducted on 148 patients with CD20+ DLBCL has shown promising results. Among the patients, 86% were diagnosed with DLBCL not otherwise specified, of which 27% exhibited DLBCL transformed from indolent lymphoma, while 14% presented HGBL. The patients had a median of 3 prior therapies, with few having undergone autologous hematopoietic stem cell transplantation (CAR T-cell) treatment and 29% being refractory to CAR T-cell therapy.

Results showed that epcoritamab-bysp provided an overall response rate of 61% and a complete response rate of 38% with a median duration of response of 15.6 months in heavily pretreated patients with R/R DLBCL. Furthermore, pyrexia, musculoskeletal pain, fatigue, CRS, injection site reactions, abdominal pain, nausea, and diarrhea, were the most common adverse reactions reported during the study.

Although the promising response rate of epcoritamab-bysp is a potential sign of development as it could be used as an alternative treatment option in relapsed/refractory DLBCL. However, the potential risks associated with the treatment should be considered before administering it to the patients.

DLBCL is an aggressive, fast-growing, and most common type of nonHodgkin’s lymphoma (NHL), with an estimated 30,400 US cases in 2022 and 150,000 new cases each year globally.

Patients with DLBCL are generally treated with chemoimmunotherapy-based regimens, while for R/R patients, several targeted therapies, such as T-cell mediated treatments, have recently emerged. Nonetheless, single-agent and readily accessible treatment options are limited.


EPKINLY™ (epcoritamab-bysp) approved by U.S. FDA as the first and only bispecific antibody to treat adult patients with relapsed or refractory diffuse large b-cell lymphoma (DLBCL). News release. AbbVie Pharmaceuticals, Inc; May 19, 2023.