Blinatumomab - Amgen

Drug Profile

Blinatumomab - Amgen

Alternative Names: AMG-103; Blincyto; MEDI-538; MT-103

Latest Information Update: 01 Aug 2018

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At a glance

  • Originator Micromet Inc
  • Developer Amgen; Astellas Pharma; M. D. Anderson Cancer Center; Merck & Co; Micromet Inc; National Cancer Institute (USA); University of California, Davis
  • Class Antineoplastics; Bispecific antibodies; Monoclonal antibodies
  • Mechanism of Action Immunostimulants; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - B cell prolymphocytic leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma; B cell lymphoma; Mantle-cell lymphoma; T cell prolymphocytic leukaemia; Chronic lymphocytic leukaemia; Hairy cell leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Phase II/III Non-Hodgkin's lymphoma
  • Phase II Diffuse large B cell lymphoma
  • Discontinued Chronic lymphocytic leukaemia

Most Recent Events

  • 27 Jul 2018 Preregistration for Precursor B cell lymphoblastic leukaemia-lymphoma (In adolescents, In children, In infants, Second-line therapy or greater) in European Union (IV) before July 2018
  • 27 Jul 2018 The Committee for Medicinal Products for Human Use of EMA adopts a negative opinion for marketing authorization of blinatumomab for the treatment of minimal residual disease in B-precursor acute lymphoblastic leukaemia
  • 27 Jul 2018 The Committee for Medicinal Products for Human Use recommends approval of blinatumomab for Precursor B cell lymphoblastic leukaemia-lymphoma (In adolescents, In children, In infants, Second-line therapy or greater) in European Union
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