The European Medicines Agency (EMA) has validated AbbVieMarketing Authorization Application (MAA) for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients after two or more lines of systemic therapy.
Simultaneously, Genmab submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the investigational subcutaneous IgG1-bispecific antibody for the treatment of patients with R/R large B-cell lymphoma (LBCL).
Both regulatory applications are supported by data obtained from the LBCL group of the multicenter, open-label, Phase II EPCORE NHL-1 study.
The study was designed to evaluate the initial efficacy and safety of the antibody in relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (NHL), including adult patients with DLBCL.
AbbVie’s vice president and head of global oncology development, Mohamed Zaki, said: “The regulatory filings for epcoritamab exemplify our drive to provide innovative care for people living with large B-cell lymphoma and diffuse large B-cell lymphoma who have limited options for treatment.
“This achievement represents an initial step in our commitment to research and deliver an important treatment option with the potential to become a major therapy for people living with B-cell malignancies such as LBCL and DLBCL.”
Co-developed by AbbVie and Genmab, epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells.
It also induces T cell-mediated killing of CD20+ cells.
AbbVie and Genmab share commercial responsibilities for epcoritamab in the US and Japan, while AbbVie holds the rights to commercialize the antibody worldwide.
Both companies are also evaluating the antibody in a Phase III randomized, open-label trial as monotherapy for patients with R/R DLBCL.