NETTER-P: Lutathera in Adolescent Patients (12-17) with GEP-NETs and PPGLs

NETTER-P: Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

CLINICALTRIALS.GOV IDENTIFIER: NCT04711135

DRUG/TREATMENT: Lutetium [177Lu] oxodotreotide/dotatate

PHASE: 1

STATUS: Recruiting

SPONSOR: Advanced Accelerator Applications (AAA)

UPDATE: 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.

Dr. Aman Chauhan Discusses "NETTER-P" Lutathera in Adolescent Patients

DESCRIPTION:

Advanced Accelerator Applications (AAA) is sponsoring a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.

For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here.

CONTACT:

Novartis Pharmaceuticals

EMAIL: Novartis.email@novartis.com

PHONE: 1-888-669-6682