Regeneron Pharmaceuticals, Inc. (REGN) announced the European Commission has approved Ordspono or odronextamab to treat adult patients with relapsed or refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, after two or more lines of systemic therapy. This marks the first regulatory approval of Ordspono. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell.
The company said the approval is based on results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL.
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