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

Anthony Stein, Janet L. Franklin, Victoria M. Chia, Deborah Arrindell (), William Kormany, Jacqueline Wright, Mandy Parson, Hamid R. Amouzadeh, Jessica Choudhry and Guiandre Joseph
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Anthony Stein: City of Hope
Janet L. Franklin: Global Patient Safety, Amgen Inc
Victoria M. Chia: Global Patient Safety, Amgen Inc
Deborah Arrindell: Global Patient Safety, Amgen Inc
William Kormany: Global Patient Safety, Amgen Inc
Jacqueline Wright: Global Patient Safety, Amgen Inc
Mandy Parson: Global Patient Safety, Amgen Inc
Hamid R. Amouzadeh: Global Patient Safety, Amgen Inc
Jessica Choudhry: Global Patient Safety, Amgen Inc
Guiandre Joseph: Global Patient Safety, Amgen Inc

Drug Safety, 2019, vol. 42, issue 5, No 3, 587-601

Abstract: 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.

Date: 2019
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DOI: 10.1007/s40264-018-0760-1

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