Regeneron's odronextamab accepted for FDA priority review

Moving the compound a step closer to regulatory approval, the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) filed by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) 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. If approved, odronextamab would be the first and only bispecific antibody approved for both FL and DLBCL – the two most common subtypes of non-Hodgkin lymphoma.

The BLA was supported by data from a Phase I and pivotal Phase II 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.