Regeneron's blood cancer therapy faces setback as FDA raises trial concerns

US drug firm operates a large facility in Limerick

Regeneron Pharmaceuticals was testing its experimental drug, odronextamab, in multiple late-stage trials in patients with follicular lymphoma.

Regeneron Pharmaceuticals said the US FDA has declined approval for its blood cancer therapy for two forms of lymphoma on concerns over the progress of ongoing confirmatory trials.

The FDA said in its response letter that it needs more data from enrollments in dose-finding and confirmatory portions of trials, delaying its decision on the drug, while confirming no issues with clinical efficacy or safety, trial design, labelling or manufacturing.