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Novartis's Lutathera approved by FDA for pediatrics patients with gastroenteropancreatic neuroendocrine tumors | News | Updates | iPharmaCenter

Novartis' radioligand therapy Lutathera has gained FDA approval as the maiden medication tailored explicitly for younger patients grappling with gastroenteropancreatic neuroendocrine tumors. This endorsement stems from the NETTER-P trial's findings, showcasing Lutathera's consistent safety record and similar medication exposure among adolescent (12-17 years old) and mature patients.


Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are an uncommon form of cancer, frequently detected in advanced stages and proving challenging to surgically remove. Novartis, an eminent figure in radioligand therapy (RLT), delves into a spectrum of RLTs aimed at combatting various cancers, encompassing GEP-NETs, lung, prostate, breast, colon, brain, and pancreatic cancers.


Novartis has recently disclosed that the FDA has granted approval for Lutathera (lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) to treat pediatric patients aged 12 and above afflicted with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. This landmark approval positions Lutathera as the premier therapy scrutinized and sanctioned for application in young patients grappling with GEP-NETs.


NETs, originating from neuroendocrine cells dispersed throughout the body, are typically perceived as indolent malignancies. However, their diagnosis often encounters delays due to the dormant nature of the disease, with approximately 10% to 20% of pediatric cases diagnosed as metastatic. Despite being classified as an orphan disease, the incidence of NETs has seen an upsurge over recent decades.


The green light from the FDA hinged on the NETTER-P trial's outcomes, which assessed Lutathera's efficacy in patients aged 12 to <18 years with SSTR+ GEP-NETs. The trial reported a safety profile mirroring that of the adult cohort scrutinized in NETTER-1, the pivotal trial that secured Lutathera's approval for adults. Moreover, the calculated radiation absorbed dose in pediatric patients adhered to established organ thresholds for external beam radiation and mirrored that in adults for the approved dosage.


Lutather (lutetium Lu 177 dotatate) holds US approval for treating adults and adolescents aged 12 and older with SSTR-positive GEP-NETs, spanning foregut, midgut, and hindgut tumors, encompassing the populations studied in the randomized, controlled Phase III trials NETTER-1 and NETTER-2. Additionally, Lutathera is endorsed 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.

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