ITM’s radiotherapeutic for GEP-NETs closer to approval
German radiopharma company ITM Isotope Technologies Munich SE (ITM) has announced that the US Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide—also known as ITM-11.
Lu-edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026.
Celine Wilke, chief medical officer of ITM, said: “The FDA’s acceptance of our NDA is an important regulatory milestone in advancing this new radiopharmaceutical treatment option for patients with GEP-NETs.
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