Regeneron Says CHMP Recommends Conditional Marketing Authorization For Odronextamab In EU
2024-06-23
4285
(fxcue news) - 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.
Sign In via X
Google
Sign In via Google
This page link：http://www.fxcue.com/19488.html
Tips：This page came from Internet, which is not standing for FXCUE opinions of this website.
Statement：Contact us if the content violates the law or your rights
Tips：This page came from Internet, which is not standing for FXCUE opinions of this website.
Statement：Contact us if the content violates the law or your rights