FDA Issues Complete Response Letter for GEP-NET Drug Due to Manufacturing Concerns

The FDA has issued a Complete Response Letter (CRL) for the new drug application of 177Lu-edotreotide (ITM-11), an investigational treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The CRL cited issues related to Chemistry, Manufacturing, and Controls (CMC) and third-party commercial facilities, requiring resolution before approval. The agency did not raise concerns regarding the drug's clinical safety or efficacy, nor did it request additional clinical data.