Regeneron Wins CHMP Backing of Lymphoma Drug Odronextamab

By Colin Kellaher

Regeneron Pharmaceuticals on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of odronextamab for certain patients with the two most-common subtypes of non-Hodgkin lymphoma.

The Tarrytown, N.Y., biotechnology company said the recommendation covers odronextamab for adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy.

The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in the coming months.

The U.S. Food and Drug Administration in March turned away Regeneron's application seeking approval of odronextamab due to issues related to the enrollment status of confirmatory trials.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

06-28-24 0744ET