FDA Approves Lutathera for Pediatric GEP-NETs


Lutathera was approved for patients 12 or older with SSTR-positive gastroenteropancreatic neuroendocrine tumors, the FDA announced.

The Food and Drug Administration (FDA) approved Lutathera (lutetium Lu 177) for the treatment of children aged 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors, the agency announced in a press release.

This is the first FDA approval of a radioactive drug for this patient population, the release noted.

The approval is based off findings from the ongoing phase 2 NETTER-P clinical trial evaluating Lutathera in patients between the ages of 12 and 17 with locally advanced or inoperable or metastatic SSTR-positive GEP-NETs or pheochromocytoma/paraganglioma (PPGL). Outcomes from NETTER-1 trial, which included 229 patients with locally advanced or inoperable or metastatic SSTR-positive midgut carcinoid tumors, were also considered by the FDA in the approval process.

READ MORE: Lutathera Plus Sandostatin Boosts Outcomes in Advanced NETs

NETTER-P included nine children, four of whom had GEP-NETS. The main goal of the trial was to measure absorbed radiation doses in certain organs, as well as the incidence of side effects after the first treatment cycle. Researchers also looked at short-term side effects.

According to the study’s listing on ClinicalTrials.gov, the estimated study completion date is May 2029.

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