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First complete response letter for lack of confirmatory trial enrollment

ARTICLE | Product Development

FDA dings Regeneron for seeking accelerated approval before launching trials to confirm benefit

By Steve Usdin, Washington Editor

March 26, 2024 12:57 AM UTC

Updated on Mar 26, 2024 at 5:50 PM UTC

Editor’s note: This article has been updated to reflect Regeneron’s compassionate use program for odronextamab

On December 29, 2022, Congress gave FDA the power to refuse to approve an application for accelerated approval if a trial to confirm clinical benefit was not under way. The agency has used that power for the first time, issuing complete response letters to Regeneron for odronextamab, a CD20xCD3 bispecific, for treatment of relapsed or refractory follicular lymphoma and relapsed or refractory diffuse large B cell lymphoma.

Announcing the CRLs Monday, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) stated that the “only approvability issue is related to the enrollment status of the confirmatory trials,” and that FDA “did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing.”…