FDA Approves Novartis' Lutathera As First Therapy For Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors

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 <18 with SSTR+ GEP-NETs7. 

The study reported a safety profile consistent with the adult population studied in NETTER-1, the pivotal trial for approval of Lutathera in adults. 

In addition, the estimated radiation absorbed dose in pediatric patients was within established organ thresholds for external beam radiation and comparable to that in adults for the approved dose.

Lutathera (lutetium Lu 177 dotatate) is approved in the US for adults and children 12 years and older with SSTR-positive GEP-NETs.

Lutathera is also approved in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults, and in Japan for SSTR-positive NETs.

Price Action: NVS shares are up 2.29% at $97.30 at the last check Tuesday.