FDA accepts epcoritamab BLA in relapsed/refractory LBCL for priority review

Denmark’s Genmab (Nasdaq: GMAB) edged up 1.3% after it announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The target action date for the FDA decision is May 21, 2023.

The application is supported by previously-announced results from the LBCL cohort of the EPCORE NHL-1 open-label, multicenter Phase I/II 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).

LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally. The acceptance of the BLA for epcoritamab signals continued progress in Genmab and AbbVie’s (LSE: ABBV) hope to develop a core therapy for people living with B-cell malignancies.