FDA approves Lutathera for children with gastroenteropancreatic neuroendocrine tumors
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The FDA approved lutetium Lu 177 dotatate for the treatment of pediatric patients aged 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut and hindgut tumors.
Lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications/Novartis) —a radiolabeled somatostatin analog — is the first FDA-approved radiopharmaceutical for pediatric patients aged 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for the same indication in adults in 2018.
The FDA based the approval on results from the multicenter NETTER-P trial, a single-arm study evaluating lutetium Lu 177 dotatate in adolescents with locally advanced/inoperable or metastatic SSTR-positive gastroenteropancreatic neuroendocrine tumors or pheochromocytoma/paraganglioma.
Extrapolated efficacy outcomes from the randomized phase 3 NETTER-1 trial — which served as the pivotal study leading to approval of lutetium Lu 177 dotatate in adults — also supported the new indication for younger patients.
“While [gastroenteropancreatic neuroendocrine tumors] in children and adolescents are rare, the impact can be devastating. Today’s approval addresses a critical need for new treatment options for these vulnerable patients,” Theodore W. Laetsch, MD, a NETTER-P trial investigator and director of the Developmental Therapeutics Program at Children’s Hospital of Philadelphia, said in a Novartis-issued press release. “The introduction of radioligand therapy significantly advanced how we treat gastroenteropancreatic neuroendocrine tumors, and I’m encouraged that younger patients now have the potential to benefit from this innovation.”
The safety results from the NETTER-1 trial remained consistent with those observed when evaluating lutetium Lu 177 dotatate in adults.
Absorbed radiation dose in target organs served as study’s primary outcome measurement and appeared to be “within established organ thresholds for external beam radiation and comparable to that in adults for the approved dose,” according to the Novartis release.
References:
- FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-nets. Published April 23, 2024. Accessed April 25, 2024.
- Novartis radioligand therapy Lutathera FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors (press release). Available at: https://www.novartis.com/news/media-releases/novartis-radioligand-therapy-lutathera-fda-approved-first-medicine-specifically-pediatric-patients-gastroenteropancreatic-neuroendocrine-tumors. Published April 23, 2024. Accessed April 25, 2024.
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