On August 10, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding its New Drug Application (NDA) for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved.
The FDA did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11. ITM is reviewing the agency’s feedback and assessing the appropriate next steps with the relevant external parties.
The Company remains confident in the potential of ITM-11 and is reviewing the FDA’s feedback to determine the most appropriate path forward. The Company intends to resubmit to complete the review of the NDA.
"Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL," said Dr. Andrew Cavey, chief executive officer of ITM. "Our pivotal COMPETE trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living with advanced GEP-NETs."
About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-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, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.
(Press release, ITM Isotopen Technologien Munchen, AUG 10, 2026, View Source [SID1234669920])