FDA Approves LUTATHERA for Peptide Receptor Radionuclide Therapy (PRRT) for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

BREAKING NEWS: On January 26, 2018 the US Food and Drug Administration approved LUTATHERA® marking the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).  The drug will be used in Peptide Receptor Radionuclide Therapy (PRRT), which is a form of targeted treatment.  LUTATHERA®(lutetium Lu 177 dotatate) is indicated for adult patients with somatostatin receptor-positive GEP-NETs, including foregut, midgut, and hindgut neuroendocrine tumors.

Click here to read the FDA press release about the approval 

Click here to read the Advanced Accelerator Applications press release about the approval 

The approval of LUTATHERA® is based on results from the NETTER-1 clinical study. Click here to read the article in the New England Journal of Medicine about the NETTER-1 study. According to carcinoid/NET specialist Dr. Jonathan Strosberg, “The findings were, in my opinion, extraordinarily impressive, the median progression-free survival improved by nearly 80%, which is fairly unprecedented in oncologic studies. The finding is important because limited therapeutic options exist for such patients, who comprise 20% to 45% of neuroendocrine tumor cases.”