FDA has approved Lutathera (lutetium Lu 177 dotatate) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
This marks a significant milestone as it’s the first FDA-approved radioactive drug, or radiopharmaceutical, for this specific pediatric population.
The approval was based on pharmacokinetic (PK), dosimetry, and safety data from the ongoing NETTER-P trial, which investigated the use of lutetium Lu 177 dotatate in adolescent patients with locally advanced/inoperable or metastatic SSTR-positive GEP-NETs or pheochromocytoma/paraganglioma (PPGL).
This international study examined the use of lutetium Lu 177 in adolescents with specific tumors. Additionally, the FDA considered the effectiveness data from the NETTER-1 trial in adults.
NETTER-P for lutetium Lu 177 in treating GEP-NET was conducted under the Best Pharmaceuticals for Children Act (BPCA) through a Written Request (WR).
The application for lutetium Lu 177 received priority review and orphan drug designation, programs designed to expedite approval for promising treatments for GEP-NET.
Source: FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-nets
