Regeneron announces FDA accepted priority review the BLA for odronextamab

Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for Priority Review the Biologics License Application, BLA, for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, DLBCL, who have progressed after at least two prior systemic therapies. The target action date for the FDA decision is March 31, 2024. 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. The BLA was supported by data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2). Results from these studies investigating odronextamab in both FL and DLBCL were last presented at the 64th American Society of Hematology Annual Meeting. Odronextamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.