FDA Grants Lutathera Priority Review for Neuroendocrine Tumors
“The FDA has granted a priority review designation to Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to the developer of the peptide receptor radionuclide therapy (PRRT), Advanced Accelerator Applications.
The application was based upon data from the phase III NETTER-1 trial, which compared Lutathera with high-dose octreotide LAR for patients with grade 1 or 2 metastatic midgut NETs. In this trial, there was a 79% reduction in the risk of progression or death with Lutathera compared with octreotide. The FDA is scheduled to make a decision on the PRRT by December 28, 2016, as part of the Prescription Drug User Fee Act (PDUFA).”