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Breaking News: Lutathera® PRRT Now Approved for Adolescents (12-17 year olds)

On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera®, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for this indication for adults in 2018.


This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs.


Full prescribing information for Lutathera® will be posted here.


Read the complete FDA announcement here.

Read the Novartis press release here.


Thanks to the investigators and patients and families who participated in the NETTER-P clinical trial to make this approval possible!

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