Gemtuzumab ozogamicin

Drug Profile

Gemtuzumab ozogamicin

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

Latest Information Update: 20 May 2017

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
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute myeloid leukaemia

Most Recent Events

  • 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
  • 01 Jan 2017 The US FDA accepts NDA for Gemtuzumab ozogamicin for Acute myeloid leukaemia for review
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at so we can help.

Back to top