ITM Isotope Technologies Munich SE's ITM-11 (Lutetium-177 [Lu-177] edotreotide) was recently granted fast-track designation by the U.S. Food and Drug Administration (FDA).
ITM-11 is an investigational radiopharmaceutical that aims to treat gastroenteropancreatic neuroendocrine tumors. It is being evaluated as a targeted radionuclide therapy in two phase III clinical trials, "Compete" and "Compose."
The fast-track designation will allow the company to work closely with the FDA to further work on the final stages of development for ITM-11 to be used in patients.
