The Food and Drug Administration has declined to approve an investigational radiation-based therapy for a form of pancreatic and gastrointestinal cancer, and the reason has nothing to do with whether the drug helps patients.
ITM Isotope Technologies Munich said it received a Complete Response Letter on August 7 for 177Lu-dotatate, known as ITM-11, an agent developed for gastroenteropancreatic neuroendocrine tumors. The letter cited chemistry, manufacturing, and controls issues, as well as items related to a third-party commercial facility. The agency did not identify any concerns with the clinical or nonclinical data package or the drug's safety profile, and the decision was issued weeks ahead of the scheduled action date of August 28.
