Abstract | PURPOSE: The pharmacology, pharmacodynamics, pharmacokinetics, efficacy in clinical trials, safety and tolerability, and place in therapy of blinatumomab are reviewed. SUMMARY:
Blinatumomab is a novel, bispecific, T-cell engaging antibody that targets tumor-associated antigens CD19 and CD3. Blinatumomab was approved through an accelerated pathway for the treatment of Philadelphia (Ph) chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). One Phase II trial found 16 of 21 patients to be negative for minimal residual disease (MRD) after one cycle of treatment, resulting in a response rate of 80%. Another Phase II trial showed an 82% MRD response, even in heavily pretreated patients. The most common adverse events of any grade noted were pyrexia, febrile neutropenia, hypokalemia, and anemia. The most frequently occurring grade 3 or 4 adverse events were febrile neutropenia, neutropenia, and anemia. Cycle 1 is dosed as a 9- μg/ day continuous i.v. infusion on days 1-7 and a 28-μg/day continuous i.v. infusion on days 8-28 administered as a four-week continuous i.v. infusion, followed by at least two weeks of no treatment. Subsequent cycles are dosed as a 28-μg/day continuous i.v. infusion on days 1-28, followed by at least two weeks of no treatment, for up to five treatment cycles. CONCLUSION:
Blinatumomab is approved as an option for Ph chromosome-negative relapsed or refractory B-cell precursor ALL and is a needed addition to the limited treatment options for this difficult-to-treat patient population. Two Phase II clinical trials resulted in impressive results when using blinatumomab as a single agent, resulting in the drug's approval.
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Authors | Megan Brafford May, Ashley Glode |
Journal | American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
(Am J Health Syst Pharm)
Vol. 73
Issue 1
Pg. e6-e13
(Jan 01 2016)
ISSN: 1535-2900 [Electronic] England |
PMID | 26683683
(Publication Type: Journal Article, Review)
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Copyright | Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved. |
Chemical References |
- Antibodies, Bispecific
- Antineoplastic Agents
- blinatumomab
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Topics |
- Animals
- Antibodies, Bispecific
(pharmacology, therapeutic use)
- Antineoplastic Agents
(pharmacology, therapeutic use)
- Clinical Trials as Topic
(methods)
- Humans
- Philadelphia Chromosome
(drug effects)
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
(drug therapy, immunology)
- T-Lymphocytes
(drug effects, immunology)
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