WASHINGTON (dpa-AFX) - ITM Isotope Technologies Munich said the U.S. Food and Drug Administration has declined to approve its application for ITM-11, an investigational treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), citing concerns related to manufacturing.
The FDA issued a Complete Response Letter on August 7, stating that the application could not be approved in its current form because of issues involving chemistry, manufacturing and controls, as well as a third-party commercial manufacturing facility. ITM said the agency did not identify concerns with ITM-11's clinical or nonclinical data or its safety profile.
The company's application was supported by results from the Phase 3 Compete trial, in which ITM-11 demonstrated an improvement in progression-free survival compared with Novartis' Afinitor, although the study did not show a statistically significant improvement in median overall survival.
ITM said it remains confident in the treatment's potential and plans to work with the FDA and its external partners to address the issues and resubmit the application.
ITM-11 contains lutetium-177, an isotope also used in Novartis' cancer treatments Pluvicto and Lutathera. The company is continuing to evaluate ITM-11 in additional Phase 3 and early-stage trials targeting other neuroendocrine tumors.
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