Tarrytown, N.Y.-based Regeneron Pharmaceuticals said the FDA declined to approve its blood cancer therapy for two forms of lymphoma over concerns about the ongoing confirmatory trials.
The company was testing its drug odronextamab in multiple phase 3 trials for patients with follicular lymphoma and diffuse large B-cell lymphoma, according to a March 25 company news release. The FDA required that the trials included both dose-finding and confirmatory portions and said "the confirmatory portions of these trials should be underway and that the timelines to completion be agreed prior to resubmission."
The FDA did not identify any issues with the drug's clinical efficacy, safety, labeling, manufacturing, nor the trial design.
"Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with R/R FL and R/R DLBCL as quickly as possible," the news release said. "Regeneron plans on sharing updates on enrollment and regulatory timelines later this year."