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Published in: Drug Safety 5/2019

Open Access 01-05-2019 | Review Article

Benefit–Risk Assessment of Blinatumomab in the Treatment of Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

Authors: Anthony Stein, Janet L. Franklin, Victoria M. Chia, Deborah Arrindell, William Kormany, Jacqueline Wright, Mandy Parson, Hamid R. Amouzadeh, Jessica Choudhry, Guiandre Joseph

Published in: Drug Safety | Issue 5/2019

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Abstract

Blinatumomab is the first-and-only Food and Drug Administration (FDA)-approved cluster of differentiation (CD) 19-directed CD3 bispecific T-cell engager (BiTE®) immunotherapy. It is currently FDA approved for the treatment of adults and children with Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-negative (Ph−) relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL) and B-cell precursor ALL with minimal residual disease. Similarly, initial marketing authorization for blinatumomab in the European Union was granted for the treatment of adults with Ph− R/R B-cell precursor ALL. The benefits of treating R/R B-cell precursor ALL patients with blinatumomab include increased overall survival, more favorable hematologic remission and molecular response rates, and a lower incidence rate of selected adverse events when compared with standard-of-care chemotherapy. The key risks associated with blinatumomab treatment include cytokine release syndrome, neurotoxicity, and medication errors. Here, we review the benefits and risks of blinatumomab treatment and describe how these risks can be mitigated.
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Metadata
Title
Benefit–Risk Assessment of Blinatumomab in the Treatment of Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
Authors
Anthony Stein
Janet L. Franklin
Victoria M. Chia
Deborah Arrindell
William Kormany
Jacqueline Wright
Mandy Parson
Hamid R. Amouzadeh
Jessica Choudhry
Guiandre Joseph
Publication date
01-05-2019
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 5/2019
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-018-0760-1

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