FDA approves lutetium Lu 177 dotatate for pediatric patients
The US Food and Drug Administration has approved Lutathera (lutetium Lu 177 dotatate, from Advanced Accelerator Applications USA, a Novartis (NOVN: VX) company).
The authorization is for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroentero-pancreatic 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 pediatric patients 12 years of age and older with SSTR-positive GEP-NETs, the FDA noted.
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