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Lutetium-177 oxodotreotide - Advanced Accelerator Applications

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Drug Profile

Lutetium-177 oxodotreotide - Advanced Accelerator Applications

Alternative Names: 177Lu-DOTA-TATE; 177Lu-DOTA0-Tyr3-Octreotate; 177Lu-labelled somatostatin analog peptide; [177Lu]Lu-DOTA-TATE; [Lu-177]-Dota-Tyr3-Octreotate; [Lu-177]-DOTATATE; AAA 601; F-1515; Lu-177-octreotate; Lu-DOTATATE; Lutate; Lutathera; LUTETIUM (177LU) OXODOTREOTIDE; Lutetium (177Lu) oxodotreotide - Advanced Accelerator Applications; Lutetium Lu 177 dotatate; lutetium Lu 177 dotatate; Lutetium-177-DOTA-Tyr-3-octreotate; Lutetium-177-DOTATATE; Octreotate Lu-177 DOTA Tyr-3; Octreotate-Lu-177

Latest Information Update: 14 Aug 2024

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At a glance

  • Originator BioSynthema
  • Developer Advanced Accelerator Applications; Australasian Gastro-Intestinal Trials Group; FUJIFILM Toyama Chemical; Georgetown University Medical Center; Gustave Roussy; King Faisal Specialist Hospital & Research Centre; National Cancer Centre (Singapore); National Cancer Institute (USA); Novartis Pharmaceuticals; NYU Langone Medical Center; Peking University; University Medical Center Utrecht
  • Class Antineoplastics; Drug conjugates; Peptides; Radioisotopes; Radiopharmaceuticals
  • Mechanism of Action Ionising radiation emitters
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Neuroendocrine tumours
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Neuroendocrine tumours
  • Phase II Glioblastoma; Meningioma; Nasopharyngeal cancer; Pancreatic cancer; Paraganglioma; Phaeochromocytoma; Small cell lung cancer

Most Recent Events

  • 29 Jul 2024 Novartis Pharmaceuticals initiates a phase I trial for Prostate cancer (Metastatic disease) in France and Spain (IV) (NCT06379217) (EudraCT2023-505655-43)
  • 18 Jul 2024 Preregistration for Neuroendocrine tumours (Newly diagnosed, Metastatic disease, Inoperable/Unresectable, In adults) in European Union (IV) before July 2024
  • 31 May 2024 Efficacy and adverse events data from the phase III NETTER-2 trial in Neuroendocrine tumours presented at 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)

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