The U.S. FDA has issued a Complete Response Letter (CRL) regarding ¹⁷⁷Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The CRL citing Chemical, Manufacturing & Controls (CMC) and third-party commercial facility inspection-related items. The CRL did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11.
The agency stated it cannot approve the NDA in its present form, delaying what had been a PDUFA goal date of August 28, 2026. The FDA cited Chemistry, Manufacturing and Controls (CMC) deficiencies and unresolved conditions at a third-party commercial manufacturing facility as the sole basis for the CRL.
The CRL did not identify any concerns with the clinical or nonclinical data package, the safety profile of ITM-11, or request any new clinical or nonclinical studies.
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