FDA rejects ITM’s ¹⁷⁷Lu-edotreotide filing
Privately-held German biopharma company Isotope Technologies Munich (ITM) revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved.
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