Regeneron Pharmaceuticals, Inc.: BLA 761303

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response.

Submit draft labeling that is responsive to the electronic communication from the FDA dated May 22, 2024. We reserve further comment on the proposed labeling until the application is otherwise adequate.

After enrollment and analysis of Part 1 (dose-finding) is completed, we recommend hat you request a meeting with the Agency to discuss trial benchmarks (e.g., enrollment goals, site activation, proportion of primary endpoint events accrued, rial completion date) to allow measurement of the progress of the trial.

You should demonstrate in your submission that your milestones are appropriate and hat, prior to approval, you will demonstrate sufficient progress in the conduct of he confirmatory portion of the confirmatory trial to provide sufficient assurance of imely completion of the trial.

To support resubmission of the BLA, you must address this deficiency.

After enrollment and analysis of Part 1 (safety run-in or dose-finding) is completed for your intended confirmatory trial(s) in follicular lymphoma, we recommend you request a meeting with the Agency to discuss trial benchmarks (e.g., enrollment goals, site activation, proportion of primary endpoint events accrued, trial completion date) to allow measurement of the progress of the trial(s).

You should demonstrate in your submission that your milestones are appropriate and that, prior to approval, you will demonstrate sufficient progress in the conduct of the confirmatory portion of the confirmatory trial(s) to provide sufficient assurance of timely completion of the trial(s).