Regeneron's lymphoma candidate odronextamab accepted for EMA review

18 August 2023

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) for its 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 EMA previously granted odronextamab Orphan Drug designation for FL and 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.

The MAA is supported by data from a Phase I and pivotal Phase II trial (ELM-1 and ELM-2) investigating odronextamab in FL and DLBL, which were last presented at the 64th American Society of Hematology Annual Meeting.

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