By Colin Kellaher
Regeneron Pharmaceuticals said the Food and Drug Administration has accepted for review its resubmitted application seeking approval of odronextamab for certain patients with one of the most-common subtypes of non-Hodgkin lymphoma.
Regeneron, which is seeking an FDA nod for odronextamab in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, said the agency set a target action date of July 30 for a decision.
The FDA last year turned away Regeneron's initial odronextamab application due to issues related to the enrollment status of confirmatory trials.
The Tarrytown, N.Y., biotechnology company on Wednesday said the FDA's acceptance of its resubmission follows the achievement of an FDA-mandated enrollment target.
Regeneron last year won European Commission approval of odronextamab as Ordspono for relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 26, 2025 07:43 ET (12:43 GMT)
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