By Colin Kellaher


Regeneron Pharmaceuticals on Monday said the U.S. Food and Drug Administration has turned away its application seeking approval of odronextamab to treat the two most common subtypes of non-Hodgkin lymphoma.

The Tarrytown, N.Y., biotechnology company, which was seeking approval in adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma who have progressed after at least two prior systemic therapies, said the FDA issued a pair of complete response letters, indicating the agency won't approve the application in its current form.

Regeneron said the only approvability issue is related to the enrollment status of the confirmatory trials, adding that the FDA didn't identify any approvability issues with the drug's clinical efficacy or safety, trial design, labeling or manufacturing.

Regeneron, which had previously won FDA priority review of its application, said the agency indicated that confirmatory portions of Phase 3 studies of odronextamab should be under way and that the timelines to completion be agreed prior to resubmission.

The company has previously said that an FDA green light would make odronextamab the first and only bispecific antibody approved in both follicular lymphoma and diffuse large B-cell lymphoma.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

03-25-24 0733ET