Gemtuzumab ozogamicin - Pfizer

Drug Profile

Gemtuzumab ozogamicin - Pfizer

Alternative Names: Anti-CD33-monoclonal-antibody-calicheamicin; Anti-CD33-monoclonal-antibody-p67-6-calicheamicin-conjugate; CDP-771; CMA-676; Gemtuzumab; HP67-6-N-acetyl-gamma-dimethyl-acbut; Human-anti-CD33-monoclonal-antibody-P67-6-calicheamicin-conjugate; Mylotarg; WAY-CMA-676

Latest Information Update: 25 Apr 2018

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At a glance

  • Originator UCB
  • Developer Pfizer
  • Class Aminoglycosides; Cytostatic antibiotics; Drug conjugates; Immunoconjugates; Monoclonal antibodies
  • Mechanism of Action 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
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute myeloid leukaemia

Most Recent Events

  • 23 Apr 2018 Registered for Acute myeloid leukaemia (Combination therapy, First-line therapy, In adolescents, In adults) in European Union, Iceland, Norway and Liechtenstein (IV)
  • 22 Feb 2018 The EMA's Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion for gemtuzumab ozogamicin for the treatment of Acute myeloid leukaemia (First-line therapy, Combination therapy, In adolescents, In adults)
  • 01 Sep 2017 Pooled adverse events data in Acute myeloid leukaemia released by Pfizer
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