AbbVie (ABBV) announced Friday that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Additionally, Genmab has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for epcoritamab for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
The regulatory submissions are supported by previously announced results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-center Phase 2 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including DLBCL.
Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies, including an ongoing Phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL.
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