Posted by Michael Wonder on 14 Nov 2025
ITM announces FDA acceptance of new drug application and PDUFA date for lutetium Lu 177 edotreotide (ITM-11) in gastro-enteropancreatic neuroendocrine tumours
13 November 2025 - 2025 - ITM Isotope Technologies today announced that the US FDA completed its filing review and accepted the company’s new drug application for lutetium Lu 177 edotreotide (also known as ITM-11).
Lu 177 edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastro-enteropancreatic neuroendocrine tumours.
The FDA has set a PDUFA goal date of 28 August 2026.
