Garching / Munich, Germany, November 13, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-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. Click here
My guess is that there has been a simultanous application for the European Medicines Agency (EMA) but they tend to move a bit slower. I will keep you posted.
Data from the trial, presented at both the 2025 ESMO Congress and NANETS Symposium, demonstrated that the radiopharmaceutical ITM-11 (177Lu-edotretide) significantly outperformed everolimus across multiple efficacy end points for patients with well-differentiated, unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Regulatory submission to FDA/EMA/MHRA etc, is anticipated following the successful COMPETE Phase 3 results presented at ESMO 2025, though ITM has not yet confirmed a specific timeline. I’ll monitor output and let you know.
Read more by clicking here
n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide).
Dosimetry, which measures the amount of radiation absorbed by tumors and normal organs, showed that 177Lu-edotreotide delivered targeted radiation to tumors while minimizing exposure to healthy tissue, supporting its favorable efficacy and safety profile. The data were presented by Dr. Emmanuel Deshayes, study investigator and nuclear medicine physician, in an oral presentation at the 38th Annual Congress of the European Association of Nuclear Medicine (EANM), held October 4-8, 2025, in Barcelona, Spain. Dr. Deshayes received the Marie Curie Award, in recognition of exceptional scientific quality and contribution to the field of nuclear medicine at the congress.
As announced in January and March 2025, the Phase 3 COMPETE trial met its primary endpoint, demonstrating a significantly longer median progression-free survival (PFS) in patients treated with investigational agent 177Lu-edotreotide compared to everolimus. A total of 309 patients were randomized to 177Lu-edotreotide (n=207) or everolimus (n=102). Dosimetry evaluations were performed in all patients treated with 177Lu-edotreotide.
ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for ITM-11 (n.c.a. 177Lu-edotreotide), an investigational radiopharmaceutical for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE.
The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. The purpose is to bring new and promising medicines to patients sooner. The Fast Track designation enables ITM to have more frequent interactions with the FDA to discuss the ITM-11 development path. It also allows rolling review of the new drug application (NDA) for ITM-11, when submitted. The rolling submission will allow ITM to submit completed sections of an application for review by FDA, rather than wait until all sections are completed.
On the heels of the approval of PRRT in USA and UK and elsewhere, here’s news of a new PRRT compound undergoing a phase 3 clinical trial. ITM Isotope Technologies Munich SE, a specialized radiopharmaceutical company, today (7th Dec 2017) announced the enrolment of the first patient recruited in Europe for the COMPETE phase III clinical trial at the University Hospital Marburg, Germany. The CEO of ITM said “This marks the starting point of COMPETE in Europe, whereby we expect a rapid increase in the number of recruits.”
COMPETE is led as an international pivotal multi-center phase III clinical trial evaluating the efficacy and safety of (no-carrier-added) n.c.a.177Lu-Edotreotide (Solucin®) and the trial is comparing it to Everolimus (Afinitor). The trial runs until Dec 2020. The enrolment requires patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The primary endpoint is progression-free survival (PFS). The study will be conducted predominantly in Europe, North America, South Africa and Australia. The first patient to be enrolled and treated was in Australia. The clinical trial document (see references below) indicates it’s for non-functional GI tumours but for non-functional and functional pNETs. The list of locations can also be found in the clinical trial document and linked below on the ITM website. The usual inclusion/exclusion rules apply but the most notable would appear to be an exclusion for those with prior exposure to any PRRT or mTor inhibitor such as Everolimus (Afinitor).
The compound under investigation, Solucin®, is known as a Targeted Radionuclide Therapy (TRT) agent, which consists of the targeting molecule Edotreotide, an octreotide-derived somatostatin analogue and ITM´s EndolucinBeta® (no-carrier-added Lutetium-177). EndolucinBeta® is a synthetic, low-energy beta-emitting isotope of Lutetium which is a recent EMA approved pharmaceutical precursor. The radiopharmaceutical Solucin® is administered as an intravenous infusion, specifically targeting and destroying the tumor cells with ionizing radiation. Solucin® received an Orphan Designation (EMA/OD/196/13) for the treatment of GEP-NET, based on early clinical experience, which has demonstrated a substantial clinical benefit with increased PFS and quality of life.
From ITM’s website … “Edotreotide contains DOTA which functions as a chelator for radioisotopes and TOC, a synthetic Somatostatin receptor ligand” (chelator and ligand are just fancy names for ‘bonding’ or ‘binding’). “The compound Edotreotide binds with high affinity Somatostatin receptors and retains both its receptor binding properties and its physiological function when labeled with 177Lu. Somatostatin receptors are predominantly overexpressed by neuroendocrine tumors. 177Lu-Edotreotide, upon binding to Somastotatin receptors in vivo is internalized and retained by tumor cells.”
“Compared to 90Y-Edotreotide, 177Lu-Edotreotide Targeted Radionuclide Therapy in NET was found to be less haematotoxic and associated with a longer median overall survival. That was highly significant for patients with low tumor uptake as well as for patients with extra hepatic and solitary metastases. In a retrospective Phase II trial 177Lu-Edotreotide showed a low uptake/dose delivered to normal organs and very high tumor-to-kidney ratio.”
References:
1. ITM Website – click here
2. Compete Clinical Trials Document – click here
3. Compete Phase 2 results – click here
4. ITM Press Release Phase 3 results – click here
click here or on the picture
Molecular Composition
• ITM-11 uses non-carrier-added (n.c.a.) lutetium-177, which offers higher specific activity and potentially improved tumor targeting.
• Lutathera uses carrier-added lutetium-177, which may result in lower specific activity and more off-target radiation.
Trial Comparator and Design
• ITM-11 (COMPETE trial) was compared against everolimus, a targeted mTOR inhibitor, without routine use of somatostatin analogues.
• Lutathera (NETTER-1 trial) was compared against octreotide LAR (Sandostatin), and included combination therapy with Lutathera + octreotide.
Patient Population and Line of Therapy
• COMPETE enrolled Grade 1–2 GEP-NETs (gastroenteric or pancreatic origin), both first- and second-line.
• NETTER-1 focused on midgut NETs, exclusively second-line after progression on somatostatin analogues.
Progression-Free Survival (PFS) Outcomes
• ITM-11 showed 23.9 months PFS vs 14.1 months for everolimus (HR: 0.67; p=0.022).
• Lutathera showed 25.0 months PFS vs 8.5 months for octreotide (HR: 0.30).
Regulatory and Strategic Positioning
• ITM-11 is being positioned as a first-line PRRT option with GEP-NET coverage and plans for FDA submission in 2025.
• Lutathera is already widely approved since 2018 onwards with established market dominance. e.g. FDA Label – LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
There’s also a Phase 3 trial known as COMPOSE designed for more aggressive well differentiated NETs at Grade 2 and 3 – read more here.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional. Some content may be generated by AI which can sometimes be misinterpreted. Please check any references attached.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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