Moxetumomab pasudotox - MedImmune

Drug Profile

Moxetumomab pasudotox - MedImmune

Alternative Names: CAT-8015; GCR-8015; HA22

Latest Information Update: 08 Jun 2018

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At a glance

  • Originator National Cancer Institute (USA)
  • Developer M. D. Anderson Cancer Center; MedImmune; National Cancer Institute (USA)
  • Class Antineoplastics; Immunotoxins; Monoclonal antibodies
  • Mechanism of Action CD22 antigen inhibitors
  • Orphan Drug Status

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

    Yes - Hairy cell leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Hairy cell leukaemia
  • Phase II Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Discontinued Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma

Most Recent Events

  • 04 Jun 2018 Efficacy and adverse events data from a phase III trial in Hairy cell leukaemia released by AstraZeneca and MedImmune
  • 23 Apr 2018 AstraZeneca initiates the MOXE early-access programme for Hairy Cell Leukemia in April 2018 (NCT03501615)
  • 04 Apr 2018 The US FDA accepts BLA for moxetumomab pasudotox for Hairy cell leukemia for review
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