The U.S. Food and Drug Administration (FDA) has approved Novartis' Lutathera (lutetium-177 [Lu-177]) DOTATATE radiopharmaceutical for treatment of pediatric patients who are 12 years old and older with somatostatin receptor (SSTR)-positive gastroentropancreatic neuroendocrine tumors (GEP-NETs).
The April 30 approval covers foregut, midgut, and hindgut tumors and follows the same indication for adults the FDA approved in 2018, according to the FDA.
Approval was based on pharmacokinetic, dosimetry, and safety data from NETTER-P, an ongoing, international, multicenter, open-label, single-arm study of Lu-177 DOTATATE in adolescent patients with locally advanced/inoperable or metastatic SSTR-positive GEP-NETs or pheochromocytoma/paraganglioma, said the FDA, adding that this is the first approval of a radiopharmaceutical for pediatric patients 12 years old and up with SSTR-positive GEP-NETs.
NETTER-P was conducted as part of a pediatric Written Request under the Best Pharmaceuticals for Children Act, the FDA stated. The application was granted priority review and orphan drug designation. A postmarketing requirement was issued to assess the long-term safety of Lu-177 DOTATATE in adolescents.
