Inotuzumab ozogamicin

Drug Profile

Inotuzumab ozogamicin

Alternative Names: CMC-544; PF-5208773; WAY-207294

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator UCB
  • Developer Children's Oncology Group; National Cancer Institute (USA); Pfizer; SWOG; University of Texas M. D. Anderson Cancer Center
  • Class Antineoplastics; Cytostatic antibiotics; Immunoconjugates; Monoclonal antibodies
  • Mechanism of Action CD22 antigen inhibitors; DNA synthesis inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Acute lymphoblastic leukaemia
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Acute lymphoblastic leukaemia
  • Phase I/II Chronic myeloid leukaemia
  • Phase I Leukaemia
  • Discontinued Diffuse large B cell lymphoma; Non-Hodgkin's lymphoma

Most Recent Events

  • 21 Feb 2017 Preregistration for Acute lymphoblastic leukaemia (Second-line therapy or greater) in USA (IV)
  • 21 Feb 2017 FDA assigns PDUFA action date of August 2017 for inotuzumab ozogamicin for acute lymphoblastic leukaemia
  • 21 Feb 2017 Inotuzumab ozogamicin receives priority review status for Acute lymphoblastic leukaemia in USA
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