- The FDA’s target date for a decision is August 28, 2026, as determined by the Prescription Drug User Fee Act (PDUFA).
Garching / Munich, Germany, November 13, 2025 – ITM, a leading company in radiopharmaceutical biotechnology, announced today that the FDA has accepted its New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (ITM-11 or 177Lu-edotreotide). This agent, developed by ITM, is a targeted radiotherapeutic being investigated for use in treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has scheduled a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026.
According to Dr. Celine Wilke, chief medical officer of ITM, the acceptance of the NDA by the FDA marks a significant step in making this new radiopharmaceutical treatment available to GEP-NETs patients. Dr. Wilke added that 177Lu-edotreotide showed a longer progression-free survival, a simple dosing schedule, and a good safety profile in the Phase 3 COMPETE trial, suggesting that it could improve the current treatment options. ITM is looking forward to working with the FDA to potentially gain approval.
The NDA for 177Lu-edotreotide is based on data from a prospective, randomized, controlled, open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or 2 GEP-NETs, who were receiving either first- or second-line treatment. The trial achieved its primary goal, demonstrating a significantly longer median mPFS in patients treated with 177Lu-edotreotide compared to those treated with everolimus, a targeted molecular therapy. The 177Lu-edotreotide group also had a significantly higher ORR compared to the everolimus group.
Dr. Andrew Cavey, CEO of ITM, stated that this milestone represents over 20 years of dedication to advancing radiopharmaceuticals, built on the company’s global isotope manufacturing, clinical expertise, and pipeline of targeted therapeutics and diagnostics. He emphasized that their main goal is to improve the lives of people with difficult-to-treat cancers.
About the COMPETE Trial
The COMPETE trial (NCT03049189) assessed 177Lu-edotreotide (ITM-11) in comparison to everolimus in patients with inoperable, progressive Grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial met its primary endpoint, with 177Lu-edotreotide showing a clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also under evaluation in the COMPOSE Phase 3 study involving patients who have well-differentiated, aggressive Grade 2 or 3, SSTR-positive GEP-NET tumors.
About ITM Isotope Technologies Munich SE
ITM is a leading radiopharmaceutical biotech company focused on developing new radiopharmaceutical therapies and diagnostics for tumors that are difficult to treat. The company aims to meet the needs of cancer patients, clinicians, and partners through excellence in the development, production, and global supply of medical radioisotopes. ITM is dedicated to improving patient outcomes and is advancing a broad precision oncology pipeline, including multiple phase 3 studies, by combining high-quality radioisotopes with various targeting molecules. Leveraging two decades of radiopharma expertise, a central position in the industry, and an established global network, ITM aims to provide patients with more effective targeted treatments to improve clinical outcomes and quality of life.
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