title: Blinatumomab: A novel, bispecific, T-cell engaging antibody.
abstract: OBJECTIVE
  The pharmacology, pharmacodynamics, pharmacokinetics, efficacy in clinical trials, safety and tolerability, and place in therapy of blinatumomab are reviewed.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Megan Brafford May, Pharm.D., BCOP, is Clinical Oncology Pharmacy Specialist, Baptist Health Lexington, Lexington, KY. Ashley Glode, Pharm.D., BCOP, is Clinical Oncology Pharmacy Specialist and Assistant Professor, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora. megan.brafford@bhsi.com.
authors.forename: Megan Brafford
authors.initials: MB
authors.lastname: May
authors.affiliation: Megan Brafford May, Pharm.D., BCOP, is Clinical Oncology Pharmacy Specialist, Baptist Health Lexington, Lexington, KY. Ashley Glode, Pharm.D., BCOP, is Clinical Oncology Pharmacy Specialist and Assistant Professor, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora.
authors.forename: Ashley
authors.initials: A
authors.lastname: Glode
mesh_terms: D000818:Animals; D018033:Antibodies, Bispecific / Q000494:pharmacology / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods; D006801:Humans; D010677:Philadelphia Chromosome / Q000187:drug effects; D015452:Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000276:immunology; D013601:T-Lymphocytes / Q000187:drug effects* / Q000276:immunology
chemical_list: D018033:Antibodies, Bispecific; D000970:Antineoplastic Agents; C510808:blinatumomab