On November 13, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026.
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"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. 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. We look forward to working closely with the FDA toward potential approval."
The NDA submission for 177Lu-edotreotide is supported by results from the Phase 3 COMPETE study, 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, revealing a significantly longer median mPFS in patients treated with agent177Lu-edotreotide compared to everolimus, a targeted molecular therapy. Patients treated with 177Lu-edotreotide also demonstrated a significantly higher ORR compared to everolimus.
"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," said Dr. Andrew Cavey, chief executive officer of ITM. "Above all, we are driven by a single focus: making a real difference for people living with hard-to-treat cancers."
About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus.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.
(Press release, ITM Isotopen Technologien Munchen, NOV 13, 2025, View Source [SID1234661164])