Inotuzumab ozogamicin

Drug Profile

Inotuzumab ozogamicin

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

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Celltech Group
  • Developer Cancer Research UK; Children's Oncology Group; National Cancer Institute (USA); Pfizer; SWOG; University College London; 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
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 17 Aug 2017 The approved US label for Inotuzumab ozogamicin carries a black box warning for hepatotoxicity, including hepatic veno-occlusive disease and increased risk of post-HSCT non-relapse mortality
  • 17 Aug 2017 Safety and efficacy data from the phase III INO-VATE ALL trial in Acute lymphoblastic leukaemia was released (NCT01564784)
  • 17 Aug 2017 Registered for Acute lymphoblastic leukaemia (Second-line therapy or greater) in USA (IV)
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