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The FDA is expected to decide on ITM-11 (177Lu-edotreotide) for GEP-NETs by 28 August 2026, based on the Phase 3 COMPETE trial results.
Written by NECNZ team
For patients living with neuroendocrine cancer, options for peptide receptor radionuclide therapy (PRRT) have been narrow: Lutathera (lutetium Lu 177 dotatate) is the only PRRT approved for GEP-NETs in most jurisdictions. That looks set to change. The United States Food and Drug Administration accepted a New Drug Application from ITM Isotope Technologies Munich for n.c.a. 177Lu-edotreotide (also called ITM-11) in November 2025, and has set a decision deadline of 28 August 2026.
The application is supported by the Phase 3 COMPETE trial, which enrolled 309 people with inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumours. Participants were randomised to either ITM-11 or to everolimus, an oral targeted therapy already used in NETs. Updated findings presented at the 2026 European Neuroendocrine Tumor Society (ENETS) annual meeting in Krakow showed median progression-free survival of 24.5 months with ITM-11 versus 14.7 months with everolimus, and an objective response rate of 33.3% versus 3.6%. The trial focused on Pan-NETs (pancreatic NETs); 178 of the participants had this primary site.
ITM-11 uses the same lutetium-177 isotope as Lutathera but pairs it with a slightly different peptide (edotreotide rather than dotatate) and is produced as a non-carrier-added formulation, which the manufacturer says allows for higher specific activity. Whether this translates into meaningful clinical differences in safety or efficacy compared with Lutathera will be a key question for clinicians once data are reviewed in detail.
Separately, the FDA in March 2026 granted tentative approval to a third product, PNT2003 from Lantheus, which is described as radioequivalent to Lutathera. Tentative approval means the application meets FDA's requirements but cannot launch until patent protections on the reference product expire in June 2026.
None of these decisions directly fund or supply PRRT in New Zealand – Medsafe registration and a Pharmac funding application would still be required for any new PRRT to be available locally. But more options at the FDA level usually translates into more competition, more supply security and, over time, more leverage for patient advocacy here.
Source 1: www.itm-radiopharma.com
Source 2: netrf.org
Source 3: lantheusholdings.gcs-web.com
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