Subcutaneous DuoBody filed with FDA for large B-cell lymphoma and for diffuse large B-cell lymphoma with the EU.- Genmab/Abbvie
Genmab announced that the company has submitted a Biologics License Application (BLA) to the FDA for subcutaneous DuoBody (epcoritamab), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Additionally, Genmab announced that AbbVie submitted a Marketing Authorization Application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, which has been validated by the European Medicines Agency (EMA).
The regulatory submissions are supported by previously announced results from the LBCL cohort of the pivotal EPCORE NHL-1 open-label, multi-center phase II clinical trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL. These results were presented in a late-breaking oral presentation as a part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA2022), on June 11, 2022, in Vienna, Austria.
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