Regeneron receives EC approval for Ordspono

27 August 2024

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) yesterday announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.

This marks the first regulatory approval of Ordspono in the world for these patients, Regeneron noted.

Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell. It follows a positive recommendation from the European Medicines Agency’s (EMA) human medicines committee (CHMP) in June. The US Food and Drug Administration (FDA) rejected approval of the drug earlier this year.

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