EU to review Regeneron’s lymphoma drug odronextamab

Tarrytown-headquartered Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for its lymphoma treatment odronextamab.

The EMA is an agency of the 27-nation European Union that is tasked with the evaluation and supervision of pharmaceutical products. Odronextamab is designed for adult patients with the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL), relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

According to Regeneron, the EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL. The MAA is supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2) investigating odronextamab in FL and DLBCL, which were presented last December at the 64th American Society of Hematology Annual Meeting.