Tuesday, Novartis AG ( NVS )  received FDA approval for its Lutathera (lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. 

This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs.

Related: Novartis Stock Gains On European Drugmaker’s Q1 Earnings Surprise, Lifts Annual Outlook.

NETs are a type of cancer that originates in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies1. 

The diagnosis of NETs is often delayed due to the inactive nature of the disease, and approximately 10% to 20% of pediatric patients are diagnosed with metastatic disease. 

The approval was based on the NETTER-P trial, which evaluated Lutathera in patients aged 12 to