A Biologics License Application was submitted to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab for the treatment of patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
A marketing authorization application for the treatment of patients with R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy was also submitted and validated by the European Medicines Agency.
Epcoritamab is an investigational immunoglobulin G1-bispecific antibody designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell mediated killing of CD20+ cells, which are a target in many B-cell malignancies, including DLBCL, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.
The regulatory submissions are supported by previously announced results from the LBCL cohort of the EPCORE NHL-1 open-label, multicenter, phase II clinical trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkin lymphoma, including DLBCL.
Source: Business Wire, October 2022
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