Regeneron Says CHMP Recommends Conditional Marketing Authorization For Odronextamab In EU
(RTTNews) - 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.
Regeneron Pharma Q2 Results Top Estimates - Update
Regeneron Pharma Expects Q4 Results To Include $24 Mln In Acquired In-process R&D Charge
Regeneron Pharma Q4 Results Top Estimates - Update
Regeneron Completes Acquiring Sanofi's Stake In Libtayo
TSX Hits New Record High As Stocks Rally On Fed Rate Cut Hopes
Powell Says Outlook, Shifting Balance Of Risks 'May Warrant' Lower Rates
Bay Street Likely To Open On Mixed Note; Powell's Speech Eyed
