(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)
