Blinatumomab: first global approval

Drugs. 2015 Feb;75(3):321-7. doi: 10.1007/s40265-015-0356-3.


Blinatumomab (BLINCYTO™) is a novel, bispecific T-cell engaging antibody that binds cluster of differentiation (CD) 19 antigens on blast cells while also binding and activating the CD3/T cell receptor complex, causing cell lysis. The antibody is being developed by Amgen as a treatment for haematological cancers that originate from B cell lines. Blinatumomab was approved by the US FDA in December 2014 for the treatment of adults with Philadelphia chromosome (Ph)-negative relapsed/refractory B-cell precursor acute lymphoblastic leukaemia (BCP-ALL). It is awaiting approval for this indication in the EU and is in phase III development in various countries. This article summarizes the milestones in the development of blinatumomab leading to its first approval for the treatment of Ph-negative BCP-ALL.

Publication types

  • Review

MeSH terms

  • Antibodies, Bispecific / administration & dosage
  • Antibodies, Bispecific / adverse effects
  • Antibodies, Bispecific / pharmacokinetics
  • Antibodies, Bispecific / therapeutic use*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / pharmacokinetics
  • Antineoplastic Agents / therapeutic use*
  • Clinical Trials as Topic
  • Drug Approval*
  • European Union
  • Humans
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*
  • United States


  • Antibodies, Bispecific
  • Antineoplastic Agents
  • blinatumomab