FDA Approves Lutetium Lu 177 Dotatate for Pediatric Patients Aged 12 and Older With GEP-NETS.

The article reports on the approval by the U.S. Food and Drug Administration (FDA) in April 2024 of lutetium Lu 177 dotatate (Lutathera) for pediatric patients aged 12 and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut and hindgut neuroendocrine tumors. Safety was evaluated in nine pediatric patients in NETTER-P, an ongoing, international, multicenter, open-label, single-arm study of the drug.