Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors


AAA today announced that following the issuance of a previously disclosed Discipline Review Letter (DRL) in November, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

No additional clinical studies were requested in the CRL and there were no comments at this time on other sections of the NDA submission.