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# FDA Accepts ITM’s NDA for Radiopharmaceutical
- URL: https://www.fdaweb.com/fda-accepts-itms-nda-for-radiopharmaceutical/
- Published: 2025-11-13T12:00:00.000Z
- Updated: 2026-09-14T15:26:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160217

FDA has accepted for review an ITM Isotope Technologies NDA for 177Lu-edotreotide (ITM-11), a targeted radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 177Lu-edotreotide is described by the company as a no-carrier-added lutetium-177–based radiotherapeutic designed to deliver targeted radiation to somatostatin receptor–positive tumors. The agency has set a user fee review action target date for 8/28/2026.

The submission is based on data from the Phase 3 COMPETE open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs. The study compared 177Lu-edotreotide with everolimus, a standard targeted therapy.

The company says COMPETE met its primary endpoint, showing a significant improvement in median progression-free survival for patients treated with ITM-11 versus everolimus. Investigators also reported a higher objective response rate in the radiopharmaceutical arm, it says.

ITM says it is also studying 177Lu-edotreotide in COMPOSE, another Phase 3 trial evaluating the agent in patients with well-differentiated, aggressive Grade 2 or Grade 3 somatostatin receptor–positive GEP-NETs.