The European Medicines Agency (EMA) has validated AbbVie’s Marketing Authorization Application (MA) for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed diffuse large B-cell lymphoma (DLGBL) /refractory (R/R) in adult patients on two or more lines of systemic therapy.
Simultaneously, Genmab has filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for the investigational subcutaneous IgG1 bispecific antibody for the treatment of patients with R/R lymphoma large B-cell (LBCL).
Both regulatory submissions are supported by data obtained from the LBCL arm of the EPCORE NHL-1 Phase II multicenter open-label trial.
The study was designed to evaluate the initial efficacy and safety of the antibody in relapsed, progressive, or refractory mature CD20+ B-cell non-Hodgkin’s lymphoma (NHL) (NHL), including adult patients with DLBCL.
Mohamed Zaki, Vice President and Global Development Head of AbbVie Oncology, said, “The regulatory submissions for epcoritamab illustrate our commitment to providing innovative care for people living with large B-cell lymphoma and diffuse large B-cell lymphoma which have limited treatment options.
“This achievement represents a first step in our commitment to scientific research and the provision of an important treatment option with the potential to become a mainstay therapy for people living with malignant B-cell tumors such as LBCL and DLBCL. “
Co-developed by AbbVie and Genmab, epcoritamab was designed to simultaneously bind to CD3 on T cells and CD20 on B cells.
It also induces T-cell mediated destruction of CD20+ cells.
AbbVie and Genmab share commercial responsibilities for epcoritamab in the United States and Japan, while AbbVie has worldwide commercialization rights to the antibody.
The two companies are also evaluating the antibody in a randomized, open-label Phase III trial as a monotherapy for patients with DLBCL R/R.
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