Octreotate Lu-177 DOTA Tyr-3

Drug Profile

Octreotate Lu-177 DOTA Tyr-3

Alternative Names: 177Lu-[DOTA0,Tyr3]octreotate; 177Lu-DOTA0-Tyr3-Octreotate; 177Lu-DOTATATE; 177Lu-labelled somatostatin analog peptide; [Lu-177]-Dota-Tyr3-Octreotate; [Lu-177]-DOTATATE; Lu-DOTATATE; Lutate; Lutathera; Lutetium (177Lu) oxodotreotide; Lutetium Lu 177 dotatate

Latest Information Update: 31 Jul 2017

$50 / €47 *
* $ price applies to USA, Canada and Latin America. € price applies to the rest of the world. Final gross prices may vary according to local VAT.

At a glance

  • Originator BioSynthema
  • Developer Advanced Accelerator Applications; Centre Hospitalier Universitaire de Quebec
  • Class Antineoplastics; 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

  • Preregistration Neuroendocrine tumours

Most Recent Events

  • 27 Jul 2017 Advanced Accelerator Applications resubmits NDA to the US FDA for Neuroendocrine tumours
  • 27 Jul 2017 Octreotate Lu-177 DOTA Tyr-3 is available on Compassionate use and Named Patient Access Programme in 10 European countries and under an Expanded Access Programme in USA for the treatment of Neuroendocrine tumours
  • 27 Jul 2017 US FDA allows an amendment to the protocol for the US Expanded Access Programme (EAP) for octreotate Lu-177 DOTA Tyr-3 for Neuroendocrine tumours
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