The US Food and Drug Administration (FDA) has granted accelerated approval to Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after 2 or more lines of systemic therapy.
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-positive cells. The approval was based on data from the open-label, multicenter, phase 2 EPCORE NHL-1 trial (ClinicalTrials.gov Identifier: NCT03625037), which was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell lymphoma.
The efficacy population included 148 patients with DLBCL not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after 2 or more lines of systemic therapy, including an anti-CD20 monoclonal antibody-containing therapy.
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Results showed an overall response rate of 61%, with 38% of patients having a complete response and 23% having a partial response. The median duration of response was 15.6 months.
Commonly reported adverse reactions included cytokine release syndrome (CRS), fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. The most common grade 3-4 laboratory abnormalities were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
The prescribing information for Epkinly includes a boxed warning regarding the potential for CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). Among 157 study participants, CRS and ICANS occurred in 51% and 6% of patients, respectively. Epkinly should only be administered by a qualified health care professional with appropriate medical support to manage severe reactions such as CRS and ICANS.
Epkinly is administered as a subcutaneous injection. The Epkinly 4 mg/0.8 mL dose is supplied as a single-dose vial that must be diluted prior to use. The Epkinly 48 mg/0.8 mL vial is supplied as ready-to-use solution that does not need dilution prior to administration.
Reference
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma. US Food and Drug Administration. News release. Published May 19, 2023. Accessed May 19, 2023.
This article originally appeared on MPR
