Lutetium Lu 177 Dotatate Approved for Pediatric Patients With GEP-NETS

The FDA has granted approval to lutetium Lu 177 dotatate (Lutathera®, Advanced Accelerator Applications USA, Inc.) 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 approval symbolizes the first FDA approval of a radiopharmaceutical for pediatric patients ≥12 years of age with SSTR-positive GEP-NETs.

This indication was previously granted approval for adults in 2018

What they studied: Efficacy was measured in the NETTER-P trial (NCT04711135) and the NETTER-1 trial (NCT01578239).

NETTER-P is an ongoing, open-label, single-arm trial studying lutetium Lu 177 dotatate in adolescent patients with locally advanced, inoperable, or metastatic SSTR-positive GEP-NETs or pheochromocytoma/paraganglioma (PPGL). Safety of lutetium Lu 177 dotatate in this trial was evaluated based on nine pediatrics patients, which included four patients with GEP-NETs.

NETTER-1 was a phase 3, multicenter, open-label trial in which 229 patients with locally advanced/inoperable or metastatic SSTR-positive midgut carcinoid tumors were enrolled. Patients were randomized 1:1 to receive either lutetium Lu 177 dotatate with long-acting octreotide or high-dose long-acting octreotide. NETTER-1 supported the approval of this indication in adults as well.

The primary efficacy end points measured were absorbed radiation doses in target organs and incidence of adverse reactions after the first treatment cycle. A key secondary end point measured was short-term adverse reactions following treatment with lutetium Lu 177 dotatate.

What they found: Estimated radiation absorbed dose results from the NETTER-P and NETTER-1 trials can be found in the prescribing information for lutetium Lu 177 dotatate.

Adverse events: The most common adverse events experienced by pediatric patients receiving lutetium Lu 177 dotatate were similar to those observed in adults.

Instructions: The recommended dosage of lutetium Lu 177 dotatate is 7.4 GBq (200 mCi) every eight weeks, plus or minus one week, for a total of four doses. Premedications and concomitant medications should be administered as recommended. A post-marketing requirement was issued to evaluate lutetium Lu 177 dotatate’s long-term safety in adolescent patients.

For More Information (2024). Study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs and PPGLs. NLM identifier: NCT04711135. (2021). A study comparing treatment with 177Lu-DOTA0-Tyr3-octreotate to octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumours (NETTER-1). NLM identifier: NCT01578239.

Lutathera® (Lutetium Lu 177 dotatate) prescribing information (2024). Novartis Pharmaceuticals Corporation. Available at:

Image credit: Ed Uthman. Licensed under CC BY-SA 2.0

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