US FDA declines to approve Regeneron’s blood cancer therapy

By Thomson Reuters Mar 25, 2024 | 6:29 AM

(Reuters) – Regeneron Pharmaceuticals said on Monday the U.S. FDA has declined to approve its blood cancer therapy for two most common subtypes of non-Hodgkin lymphoma due to an issue related to enrollment of its confirmatory trials.

The U.S. Food and Drug Administration’s decision dealt a blow to the company that was looking to expand its oncology portfolio beyond its lone approved cancer drug, Libtayo.

In its so-called complete response letter (CRL), the FDA said the trials need to include data on both dose-finding and confirmatory portions.

Regeneron said it was working closely with the FDA, and plans on sharing updates on enrollment and regulatory timelines later this year.

(Reporting by Sneha S K, Puyaan Singh and Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)