FDA Issues Complete Response Letter for Lutathera in Neuroendocrine Tumors

23 dicembre 2016 – The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted. The CRL, which follows a discipline review letter(DRL) issued in November, requests new subgroup data, a safety update, and … (leggi tutto)