ITM Isotope Technologies Munich SE announced that the U.S. Food and Drug Administration has completed its filing review and accepted the company's New Drug Application for n.c.a. 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent for treating gastroenteropancreatic neuroendocrine tumors. The FDA has established a Prescription Drug User Fee Act goal date of August 28, 2026 for its review decision.
Phase 3 COMPETE Trial Results Drive NDA Submission
The NDA submission is supported by results from the Phase 3 COMPETE study (NCT03049189), a prospective, randomized, controlled, open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs as a first- or second-line treatment. The trial met its primary endpoint, demonstrating that 177Lu-edotreotide achieved a significantly longer median progression-free survival compared to everolimus, a targeted molecular therapy.
Patients treated with 177Lu-edotreotide also demonstrated a significantly higher objective response rate compared to everolimus. According to Dr. Celine Wilke, chief medical officer of ITM, "In the Phase 3 COMPETE trial, 177Lu-edotreotide demonstrated extended PFS, a straightforward dosing regimen, and a favorable safety profile, supporting its potential to improve the current treatment paradigm."
Expanding Clinical Development Program
Beyond the COMPETE trial, 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors, indicating the company's broader development strategy for this radiotherapeutic agent.
Regulatory Milestone for Radiopharmaceutical Innovation
"The FDA's acceptance of our NDA is an important regulatory milestone in advancing this new radiopharmaceutical treatment option for patients with GEP-NETs," said Dr. Wilke. "We look forward to working closely with the FDA toward potential approval."
Dr. Andrew Cavey, chief executive officer of ITM, emphasized the significance of this achievement: "This milestone reflects more than 20 years of leadership and dedication to advancing the radiopharmaceutical field, built on our global isotope manufacturing, clinical expertise, and pipeline of targeted therapeutics and diagnostics. Above all, we are driven by a single focus: making a real difference for people living with hard-to-treat cancers."
ITM positions itself as a leading radiopharmaceutical biotech company dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. The company advances a broad precision oncology pipeline, including multiple phase 3 studies, combining high-quality radioisotopes with a range of targeting molecules.
