ITM Isotope Technologies Munich has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for lutetium-177 edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The CRL, dated August 7, stated that the FDA is unable to approve the NDA in its present form and cited chemistry, manufacturing, and controls and third-party commercial facility-related items that must be addressed before the application can be approved, the company noted.
The FDA did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11, ITM said. ITM is reviewing the agency’s feedback and assessing the appropriate next steps with the relevant external parties.
