Genmab to submit BLA for epcoritamab with FDA

Danish biotech company Genmab (Nasdaq: GMAB) has announced its intent to submit a biologics license application (BLA) to the US Food and Drug Administration (FDA) for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of 2022.

The BLA submission is supported by results from the large b-cell lymphoma (LBCL) cohort of the pivotal EPCORE NHL-1 open-label, multicenter 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). The FDA granted Orphan status for epcoritamab in March this year.

In April 2022, Genmab and AbbVie announced the  top-line results from EPCORE NHL-1 trial. In June 2022,  primary results were presented in a late-breaking oral presentation as part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA2022) in Vienna, Austria.