Regeneron Pharmaceuticals, Inc. (REGN) disclosed on Monday that the FDA has issued Complete Response Letters, rejecting the approval of the Biologics License Application for Odronextamab in relapsed/refractory follicular lymphoma and in R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy.
This decision was made due to an issue concerning the enrollment status of the confirmatory trials.
Regeneron intends to share updates on enrollment and regulatory timelines later this year.
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