WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) announced
Friday that the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion recommending
conditional marketing authorization of odronextamab to treat adults with
relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell
lymphoma (DLBCL), after two or more lines of systemic therapy.

The European Commission is expected to announce a final decision in the coming
months. FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin
lymphoma (B-NHL).

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.

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.

Regeneron continues to evaluate the use of odronextamab as a monotherapy and in
combination across earlier lines of therapy in challenging-to-treat lymphomas.



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