{"id":46630,"date":"2024-05-15T07:00:00","date_gmt":"2024-05-15T07:00:00","guid":{"rendered":"http:\/\/b4d9b0921f1a5d8c7268e9439fdf2b83"},"modified":"2024-11-03T15:11:50","modified_gmt":"2024-11-03T15:11:50","slug":"fda-approves-lutetium-lu-177-dotatate-for-paediatric-patients-12-years-and-older-with-gep-nets","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-lutetium-lu-177-dotatate-for-paediatric-patients-12-years-and-older-with-gep-nets\/","title":{"rendered":"FDA Approves Lutetium Lu 177 Dotatate for Paediatric Patients 12 Years and Older with GEP-NETs"},"content":{"rendered":"<p>On 23 April 2024, the US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for paediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours. Lutetium Lu 177 dotatate <a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-lutetium-lu-177-dotatate-treatment-gep-nets\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">received approval<\/a> for this indication for adults in 2018.<\/p>\n<p>This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for paediatric patients 12 years of age and older with SSTR-positive GEP-NETs.<\/p>\n<p>Approval was based on pharmacokinetic, dosimetry, and safety data from NETTER-P (NCT04711135), an ongoing, international, multicentre, open-label, single-arm study of lutetium Lu 177 dotatate in adolescent patients with locally advanced\/inoperable or metastatic SSTR-positive GEP-NETs or pheochromocytoma\/paraganglioma. Approval was also based on the extrapolation of efficacy outcomes observed in NETTER-1 (NCT01578239), a randomised, multicentre, open-label, active-controlled study in 229 patients with locally advanced\/inoperable or metastatic SSTR-positive midgut carcinoid tumours, which supported the original approval of lutetium Lu 177 dotatate in adult patients.<\/p>\n<p>Safety was evaluated in 9 paediatric patients in NETTER-P, including 4 patients with GEP-NETs. The major outcome measures were absorbed radiation doses in target organs and incidence of adverse reactions after the first treatment cycle. Additional outcome measures included short-term adverse reactions following treatment with lutetium Lu 177 dotatate. The adverse reaction profile observed in NETTER-P was similar to that observed in adults.<\/p>\n<p>The recommended lutetium Lu 177 dotatate dose is 7.4 GBq (200 mCi) every 8 weeks (\u00b1 1 week) for a total of 4 doses. Premedications and concomitant medications should be administered as recommended. A post-marketing requirement was issued to assess the long-term safety of lutetium Lu 177 dotatate in adolescents.<\/p>\n<p>NETTER-P was conducted as part of a paediatric Written Request under the Best Pharmaceuticals for Children Act. This application was granted priority review and orphan drug designation.<\/p>\n<p>Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n<p>For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/oncology-center-excellence\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">Oncology Center of Excellence<\/a>&nbsp;<a href=\"https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/project-facilitate\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">Project Facilitate<\/a>.<\/p>\n<p><a href=\"https:\/\/www.esmo.org\/oncology-news\/fda-approves-lutetium-lu-177-dotatate-for-paediatric-patients-12-years-and-older-with-gep-nets\">Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>On 23 April 2024, the US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for paediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours. Lutetium Lu 177 dotatate received approval for this [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-46630","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46630","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=46630"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46630\/revisions"}],"predecessor-version":[{"id":47034,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/46630\/revisions\/47034"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=46630"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=46630"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=46630"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}