The FDA has approved lutetium Lu 177 dotatate for pediatric patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
The FDA has approved lutetium Lu 177 dotatate (Lutathera; Advanced Accelerator Applications USA [Novartis]) for patients with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) aged 12 years and older, according to a press release from the federal agency.1
The indication includes foregut, midgut, and hindgut neuroendocrine tumors. The decision by the FDA makes lutetium Lu 177 dotatate the first FDA approval of a radioactive drug, or radiopharmaceutical for the aforementioned population.1
The approval was based on pharmacokinietic, dosimetry, and safety data demonstrated in the ongoing, multicenter, international, open-label, single-arm phase 2 NETTER-P trial (NCT04711135). The study enrolled 11 patients aged 12 to <18 years.1,2
The study schedule consists of an up to 2-week screening period, followed by 4 treatment administrations at 8-week intervals, and a 5-year follow-up period.2
The approval was also based on efficacy outcomes observed in the NETTER-1 study (NCT01578239) that featured 229 patients aged 18 years and older in a randomized, multicenter, open-label, active-controlled, phase 3 design.1,3
In the NETTER-P study, safety was evaluated in 9 pediatric patients,4 of which with GEP-NETs. Major outcome measures were "absorbed radiation doses in target organs and incidence of adverse reactions after the first treatment cycle," the FDA stated.1
The recommended dose for lutetium Lu 177 dotatate is GBq (200 mCi) every 8 weeks (± 1 week) for a total of 4 doses. Premedications and concomitant medications should be administered as recommended.1
The FDA noted that a post-marketing requirement was issued to assess long-term safety of the radioactive drug in adolescents.1
The NETTER-P study was conducted as part of a pediatric Written Request under the Pharmaceuticals for Children Act. The application for lutetium Lu 177 dotatate was granted Priority Review and Orphan Drug Designation by the FDA.1
References:
1. FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS. FDA. Press release. April 23, 2024. Accessed April 23, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-nets
2. Study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs and PPGLs. ClinicalTrials.gov. Updated February 15, 2024. Accessed April 23, 2024. https://clinicaltrials.gov/study/NCT04711135
3. A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours (NETTER-1). ClinicalTrials.gov. Updated April 4, 2022. Accessed April 23, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT01578239
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