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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; Mylotarg; WAY-CMA-676

Latest Information Update: 29 May 2024

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At a glance

  • Originator UCB
  • Developer National Cancer Institute (USA); Pfizer; Technische Universitat Dresden
  • Class Aminoglycosides; Antineoplastics; Cytostatic antibiotics; Drug conjugates; Immunoconjugates; Monoclonal antibodies
  • Mechanism of Action DNA damage stimulants
  • 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

  • 22 May 2024 OHSU Knight Cancer Institute and Pfizer suspends a phase I trial due to accrual goal for Acute myeloid leukemia (Combination therapy, Newly diagnosed, First-line therapy) in the US (NCT03900949)
  • 27 Apr 2023 9387040- No updates
  • 31 Mar 2023 Pfizer completes a phase III trial in Acute myeloid leukaemia (Combination therapy, In children, In adolescents, Second-line therapy or greater) in United Kingdom, Switzerland, Sweden, Spain, Slovenia, Slovakia, Netherlands, Italy, Ireland, Hungary, Germany, France, Finland, Denmark, Czech Republic, Belgium, Austria (IV) (ISRCTN14207975)
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