ITM Isotope Technologies Munich has received a Complete Response Letter from FDA for its New Drug Application for investigational radiopharmaceutical ^177Lu-edotreotide, also known as ITM-11, in gastroenteropancreatic neuroendocrine tumors.
FDA said it could not approve the application in its current form, citing chemistry, manufacturing and controls issues as well as matters related to a third-party commercial facility. The agency did not identify concerns about the therapy’s clinical or nonclinical data package, safety profile or efficacy, and did not request additional clinical or nonclinical data.
ITM said it is reviewing FDA’s feedback and assessing next steps with relevant external parties. The company intends to resubmit the application to complete the agency’s review.
The Complete Response Letter was issued Aug. 7, three weeks before the application’s previously disclosed FDA action date of Aug. 28. FDA had accepted ITM’s application for filing in November 2025.
^177Lu-edotreotide is a targeted radionuclide therapy under development for patients with gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. The therapy is designed to target somatostatin receptor-positive tumors and deliver radiation directly to cancer cells.
The application is supported by results from the Phase 3 COMPETE trial, which compared ^177Lu-edotreotide with everolimus in patients with grade 1 or grade 2, well-differentiated GEP-NETs. ITM said the study met its primary endpoint, demonstrating clinically and statistically significant improvement in progression-free survival.
Andrew Cavey, ITM’s chief executive officer, said the company remains confident in the treatment’s potential and is committed to working with FDA and its partners to address the items identified in the letter. He said the COMPETE data package remains intact and the company’s goal is still to bring the therapy to patients with advanced GEP-NETs.
ITM-11 remains investigational and is not approved by any regulatory authority for any intended use. The company is also evaluating the therapy in its Phase 3 COMPOSE trial for patients with well-differentiated, high-grade 2 and grade 3 GEP-NETs.
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