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Lutetium (177Lu) oxodotreotide - Advanced Accelerator Applications

Drug Profile

Lutetium (177Lu) oxodotreotide - Advanced Accelerator Applications

Alternative Names: 177Lu-DOTA0-Tyr3-Octreotate; 177Lu-DOTATATE; 177Lu-labelled somatostatin analog peptide; [Lu-177]-Dota-Tyr3-Octreotate; [Lu-177]-DOTATATE; F-1515; Lu-177-octreotate; Lu-DOTATATE; Lutate; Lutathera; 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: 06 Jun 2019

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At a glance

  • Originator BioSynthema
  • Developer Advanced Accelerator Applications; Australasian Gastro-Intestinal Trials Group; FUJIFILM Pharma; Georgetown University Medical Center; Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori; King Faisal Specialist Hospital & Research Centre; National Cancer Institute (USA); NYU Langone Medical Center; Peking University; University Medical Center Utrecht
  • Class Antineoplastics; Peptides; Radiopharmaceuticals
  • Mechanism of Action Somatostatin receptor antagonists
  • 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 Meningioma; Phaeochromocytoma
  • Phase I/II Small cell lung cancer

Most Recent Events

  • 15 May 2019 Phase-II clinical trials in Meningioma in USA (IV) (NCT03971461)
  • 24 Apr 2019 Launched for Neuroendocrine tumours (Inoperable/Unresectable, Metastatic disease) in Netherlands (IM)
  • 07 Feb 2019 Registered for Neuroendocrine tumours (Inoperable/Unresectable, Metastatic disease) in Canada (IM)
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