FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concerns

FDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues.

The agency said there were no concerns about the drug's safety or efficacy, which had previously shown superiority over everolimus in a Phase 3 trial for gastroenteropancreatic neuroendocrine tumors.

ITM Isotope said it is reviewing the FDA's comments and will address the CMC and facility matters before submitting a revised application.

The company remains confident in the therapy's potential and plans to resubmit once the issues are resolved.