lutathera

FDA: Lutathera Action Date Set for Late January 2018

Advanced Accelerator Applications S.A. (AAA) has announced that the Food and Drug Administration (FDA), in the United States, has accepted and considered complete the resubmission of the New Drug Application (NDA) for its investigational drug lutetium Lu 177 dotatate (Lutathera).  Lutathera is the brand name for the radiologic used in Peptide Receptor Radionuclide Therapy (PRRT). The FDA has set an action date of Jan 26, 2018. AAA is attempting to obtain U.S.

Expanded Access to PRRT in the United States

We have exciting news in regards to Peptide Receptor Radionuclide Therapy (PRRT) therapy in the United States. Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). Considering that Phase III NETTER-1 clinical trial recruitment has been completed, this expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to