Gemtuzumab ozogamicin

Drug Profile

Gemtuzumab ozogamicin

Alternative Names: Anti-CD33-monoclonal-antibody-calicheamicin; Anti-CD33-monoclonal-antibody-p67-6-calicheamicin-conjugate; CDP 771; CMA 676; hp67.6-calicheamicin; Human-anti-CD33-monoclonal-antibody-P67-6-calicheamicin-conjugate; Mylotarg; WAY-CMA 676

Latest Information Update: 14 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 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

  • 11 Jul 2017 Oncologic Drug Advisory Committee recommends approval of gemtuzumab ozogamicin for Acute myeloid leukemia in USA
  • 01 Feb 2017 Preregistration for Acute myeloid leukaemia (In adults, First-line therapy) in USA (IV)
  • 01 Feb 2017 FDA assigns PDUFA action date of 01/09/2017 for Gemtuzumab ozogamicin for Acute myeloid leukaemia
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