Novartis' Lutathera (lutetium-177 [Lu-177]) DOTATATE radiopharmaceutical has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric patients aged 12 and above with somatostatin receptor (SSTR)-positive gastroentropancreatic neuroendocrine tumors (GEP-NETs). This approval adds to the existing indication for adults that was approved in 2018. The FDA based its approval on the data from an ongoing international study called NETTER-P, which involved adolescent patients with locally advanced/inoperable or metastatic SSTR-positive GEP-NETs. This is the first time a radiopharmaceutical has been approved for pediatric patients aged 12 and up with SSTR-positive GEP-NETs. The application for approval received priority review and orphan drug designation, and a postmarketing requirement was issued to evaluate the long-term safety of Lu-177 DOTATATE in adolescents.
Wed, 01 May 2024 17:57:16 GMT | AuntMinnie