FDA grants fast track designation to ITM-11 for gastroenteropancreatic neuroendocrine tumors
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The FDA granted fast track designation to ITM-11 for treatment of gastroenteropancreatic neuroendocrine tumors.
ITM-11 (ITM Isotope Technologies Munich SE) consists of two components: lutetium-177 — a non-carrier-added medical radioisotope — and edotreotide, a synthetic targeting molecule of the peptide hormone somatostatin that targets neuroendocrine tumor-specific receptors. Edotreotide binds to these receptors and places lutetium-177 onto the diseased neuroendocrine cells to accumulate and destroy the tumor tissue.
“We are dedicated to helping people living with hard-to-treat cancers through our research and development of innovative treatments. Receiving fast track designation provides us the opportunity to work closely with the FDA to optimize and accelerate the final stages of development for ITM-11, bringing our radiotherapeutic to patients [with gastroenteropancreatic neuroendocrine tumors] as fast as possible,” Steffen Schuster, CEO of ITM, said in a release.
ITM-11 is being evaluated as a targeted radionuclide therapy through two phase 3 clinical trials, COMPETE and COMPOSE.
The international, randomized, open-label, multicenter phase 3 clinical studies are evaluating the efficacy and safety of ITM-11 compared with standard therapy for patients with inoperable, progressive grade 1/grade 2 and aggressive grade 2/grade 3 somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin.
PFS will serve as the primary endpoint of both studies. Secondary outcome measures include OS.
Editor's note: On Nov. 2, we corrected this story to clarify that the FDA granted fast track designation to ITM-11. The editors regret this error.
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