FX.co ★ Regeneron Says FDA Rejects BLA Approval For Odronextamab In Follicular Lyphoma

Regeneron Pharmaceuticals, Inc. revealed on Monday that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters, effectively declining the approval of the Biologics License Application for Odronextamab. The pharmaceutical company was looking to use the drug in the treatment of follicular lymphoma that has relapsed or is resistant (R/R), and in R/R diffuse large B-cell lymphoma after systemic therapy has been tried two or more times.

The FDA made this decision based on an issue with the enrollment status for confirmatory trials. Regeneron Pharmaceuticals has indicated that they will provide updates on both enrollment numbers and future regulatory timings later in the year.