Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

Clinical Trials
Garching / Munich, October 27, 2022    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…
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All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

Clinical Trials, Treatment
Update June 6th 2021. Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera. New analysis of the NETTER-1 trial data has been published. For those who just need a quick summary, the quote from Dr Jonothan Strosberg is below. Short PRRT PrimerWhat is Peptide Receptor Radionuclide Therapy (PRRT)?For those who are still not sure what it's all about. This is a non-surgical treatment which is normally administered intravenously. It's based on the use of somatostatin receptors to attract a 'radiopeptide'. The radiopeptide is a combination of a somatostatin analogue and a radioactive material. As we already know, somatostatin analogues (i.e. Lanreotide/Octreotide) are a NET cell targeting drug using somatostatin receptors, so when combined with radioactivity, it binds with…
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