Blinatumomab

Drug Profile

Blinatumomab

Alternative Names: AMG-103; Anti-CD19 BiTE antibody; Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody; Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody; Blincyto; MEDI-538; MT-103

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Micromet Inc
  • Developer Amgen; Astellas Pharma; M. D. Anderson Cancer Center; 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 - Mantle-cell lymphoma; B cell prolymphocytic leukaemia; Acute lymphoblastic leukaemia; B cell lymphoma; T cell prolymphocytic leukaemia; Chronic lymphocytic leukaemia; Hairy cell leukaemia
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 01 Aug 2017 Amgen initiates enrolment in a phase I/II trial for Acute lymphoblastic leukaemia (Combination therapy, Second-line therapy or greater) in USA (IV) (NCT03160079)
  • 28 Jul 2017 Adverse events data from the phase III TOWER study in Acute lymphoblastic leukaemia presented at the 22nd Congress of the European Haematology Association (EHA-2017)
  • 11 Jul 2017 US FDA approves sBLA for blinatumomab to extend treatment to Ph(+) B-cell precursor Acute lymphoblastic leukaemia (Second-line therapy or greater) and converts accelerated approval to full approval in USA
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