ITM Receives FDA Fast Track Designation for Radionuclide Therapy Candidate ITM-11 (n.c.a. 177Lu-edotreotide) in Neuroendocrine Tumors (GEP-NETs)

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.

“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 GEP-NET patients as fast as possible,” commented Steffen Schuster, CEO of ITM.

GEP-NETs are rare types of tumors originating in the pancreas or other parts of the gastrointestinal tract. Due to their heterogeneity and unique characteristics, early diagnosis is difficult, increasing the likelihood of metastatic disease and severely limiting treatment options. ITM is developing ITM-11 to provide patients with a new, targeted treatment approach to these difficult-to-treat tumors with the goal to improve clinical outcome and quality of life.

COMPETE (NCT03049189) and COMPOSE (NCT04919226) are international, prospective, randomized, controlled, open-label, multi-center phase III clinical studies to evaluate the efficacy and safety, of ITM-11 compared to standard therapy in patients with inoperable, progressive, grade 1 and 2 (COMPETE) and aggressive grade 2 and 3 (COMPOSE), somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs). The primary endpoint of the studies is progression-free survival (PFS), and secondary outcome measures include overall survival (OS). Patient recruitment for COMPETE was completed with 300 randomized patients in April 2022.