Inotuzumab ozogamicin

Drug Profile

Inotuzumab ozogamicin

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

Latest Information Update: 22 Jun 2017

Price : $50

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

  • Preregistration 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

  • 16 May 2017 Alliance for Clinical Trials in Oncology, in collaboration with National Cancer Institute, plans a phase III trial for Acute lymphoblastic leukaemia (Newly diagnosed) (NCT03150693)
  • 24 Apr 2017 Inotuzumab ozogamicin is available on an Expanded Access Programme (NCT03127605)
  • 21 Apr 2017 Committee for Medicinal Products for Human Use (CHMP) of the EMA recommends approval of inotuzumab ozogamicin for Acute lymphoblastic leukaemia (Second-line therapy or greater) in European Union
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