FDA Approves Epcoritamab-bysp in Treatment of Resistant DLBCL

By: JNCCN 360 Staff
Posted: Wednesday, May 24, 2023

On May 19, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved epcoritamab-bysp (Epkinly), a T-cell–engaging bispecific antibody, in the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This agent is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.

The approval is based on the results of the phase I/II EPCORE NHL-1 clinical trial. In the expansion cohort of this trial, 148 patients with CD20-positive DLBCL were enrolled; 86% were diagnosed with DLBCL NOS, including 27% with DLBCL transformed from indolent lymphoma, and 14% were diagnosed with high-grade B-cell lymphoma. A total of 30% received two prior therapies, 30% received three prior therapies, and 40% received at least four prior therapies. The overall response rate with epcoritamab-bysp was 61%, the complete response rate was 38%, and the median duration of response was 15.6 months in heavily pretreated patients with relapsed or refractory DLBCL.

The prescribing information for epcoritamab-bysp has a boxed warning for serious or life-threatening cytokine-release syndrome and immune effector cell–associated neurotoxicity syndrome. Warnings and precautions include infections, cytopenias, and embryofetal toxicity. The most common (≥ 20%) adverse reactions associated with epcoritamab-bysp were cytokine-release syndrome, fatigue, musculoskeletal pain, injection-site reactions, pyrexia, abdominal pain, nausea, and diarrhea.

U.S. Food and Drug Administration

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