Gemtuzumab ozogamicin

Drug Profile

Gemtuzumab ozogamicin

Alternative Names: CDP 771; CMA 676; hp67.6-calicheamicin; Mylotarg; WAY-CMA 676

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator UCB
  • Developer Pfizer
  • Class Aminoglycosides; Cytostatic antibiotics; Drug conjugates; Immunoconjugates; Monoclonal antibodies
  • Mechanism of Action CD33 antigen inhibitors; DNA inhibitors
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute myeloid leukaemia

Most Recent Events

  • 15 Mar 2016 Biomarkers information updated
  • 09 Dec 2014 Safety and adverse events data from two investigator-led phase III trials in Acute myeloid leukaemia released by Pfizer
  • 18 Dec 2013 Discontinued - Preregistration for Acute myeloid leukaemia in European Union (IV)
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