FDA CRL - Regeneron Pharmaceuticals, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals, Inc. regarding its Biologics License Application (BLA 761303/Original 1) for odronextamab. The FDA determined that the application cannot be approved in its current form, primarily due to a significant clinical deficiency related to a required confirmatory trial for odronextamab in follicular lymphoma. Based on Federal Food, Drug, and Cosmetic Act sections 506(c)(2)(A)(i) and (D), the Agency found that the confirmatory trial is not considered sufficiently underway to provide assurance of timely completion. Regeneron must demonstrate adequate progress in these confirmatory trials. Additional required actions for resubmission include a comprehensive safety update, encompassing new clinical data, retabulation of adverse events, case reports for serious events, updated exposure information, and a summary of worldwide safety experience. Comments on proposed prescribing information, carton/container labeling, and the medication guide are reserved until other deficiencies are addressed, and the proprietary name needs to be resubmitted with the complete response. To proceed, Regeneron must address all identified deficiencies, particularly the progress of the confirmatory trial, and provide the extensive safety update. The company is advised to request a meeting with the Agency to discuss trial benchmarks after completing the initial phase of the confirmatory trial(s). A full resubmission is required within one year; the product cannot be marketed until approved.