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Moxetumomab pasudotox - AstraZeneca

Drug Profile

Moxetumomab pasudotox - AstraZeneca

Alternative Names: CAT-8015; CD22-directed immunotoxin; GCR-8015; HA22; LUMOXITI; Lumoxiti; Moxetumomab pasudotox-tdfk

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator National Cancer Institute (USA)
  • Developer AstraZeneca; M. D. Anderson Cancer Center; MedImmune; National Cancer Institute (USA)
  • Class Antineoplastics; Drug conjugates; Immunotoxins; Monoclonal antibodies
  • Mechanism of Action Apoptosis stimulants; Peptide elongation factor 2 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

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

Most Recent Events

  • 08 Feb 2021 Registered for Hairy cell leukaemia (Second-line therapy or greater) in European Union, Norway, Liechtenstein, Iceland (IV)
  • 01 Jan 2021 The CHMP recommends approval of moxetumomab pasudotox for hairy cell leukaemia (Late-stage disease, Second-line therapy or greater) in the EU
  • 11 Dec 2020 Innate Pharma plans to return the US and EU commercialisation rights of moxetumomab pasudotox-tdfk to AstraZeneca in 2021
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