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Gemtuzumab ozogamicin - Pfizer

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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: 09 Jan 2026

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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

  • 09 Jan 2026 No development reported - Phase-III for Acute myeloid leukaemia (Combination therapy, Second-line therapy or greater, In adolescents, In children) in Slovakia (IV)
  • 09 Jan 2026 No development reported - Phase-III for Acute myeloid leukaemia (Combination therapy, Second-line therapy or greater, In adolescents, In children) in Switzerland (IV)
  • 09 Jan 2026 No development reported - Phase-III for Acute myeloid leukaemia (In adolescents, Combination therapy, Second-line therapy or greater, In children) in Belgium (IV)

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