The FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, a Novartis company) for pediatric patients aged 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for this indication for adults in 2018.
This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for
APRIL 24, 2024