Regeneron announces positive CHMP opinion for odronextamab

Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, after two or more lines of systemic therapy. The European Commission is expected to announce a final decision in the coming months. The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. In a pooled safety population, the most common serious adverse reactions were cytokine release syndrome, pneumonia, COVID-19 and pyrexia. The EMA previously granted odronextamab Orphan Designation for both FL and DLBCL. Odronextamab is currently under clinical development and has not been approved by any regulatory authority.