FDA Rejects ITM-11 Radiopharmaceutical, Stalling Rival to Novartis Therapy
The FDA rejected ITM-11, ITM Isotope Technologies Munich’s radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors, due to manufacturing issues, halting a potential rival to Novartis’ therapy; early ITM data suggested ITM-11 could extend progression-free survival (23.9 months vs 14.1 months with everolimus).