Blinatumomab use in pediatric ALL: Taking a BiTE out of preparation, administration and toxicity challenges

Abstract

Blinatumomab is the first in its class bispecific T-cell engager monoclonal antibody, which binds to CD19 expressed on B-cells and CD3 expressed on T-cells, resulting in lysis of CD19-positive cells common in B-cell malignancies. Blinatumomab is Food and Drug Administration (FDA) approved for the treatment of adults and children with relapsed/refractory or minimal residual disease (MRD) positive precursor B-cell ALL (B-ALL). Despite impressive efficacy for the approved indications and favorable toxicity profile compared to standard-of-care chemotherapy, blinatumomab presents unique health-system challenges related to preparation, administration, toxicity monitoring and medication error prevention. Blinatumomab delivery also offers plethora of opportunities for interdisciplinary planning and collaboration. The purpose of this paper is to discuss practical considerations for safe blinatumomab delivery from the pharmacy and nursing perspectives.

Children's Oncology Group's 2023 blueprint for research: Pharmacy

“…This includes information regarding medications that require complex calculations, manipulations, or specialized handling. Members of the Discipline have a long‐standing relationship with Nursing Discipline members and have shared our efforts externally to help generalize study‐related knowledge for general patient care 5 . Finally, the Discipline collaborates with study sponsors to develop protocol information and provide solutions for patients who are unable to swallow oral solid dosage forms or cannot tolerate medication excipients 6 …”

Antibody and Cellular-Based Therapies for Pediatric Acute Lymphoblastic Leukemia: Mechanisms and Prospects

“…However, significant attention should be paid to the two main adverse events related to the clinical trials of blinatumumab treatment, cytokine release syndrome (CRS), and neurotoxicity. Moreover, it should be noted that the half-life of blinatumomab is only 2.1 h due to the lack of Fc fragment and low molecular weight [32]. Therefore, several efforts are needed to maintain a balance between patient intake and output.…”

Characterization of novel CD19-specific VHHs isolated from a camelid immune library by phage display

“…The clinical success of CD19-based treatment modalities eventually led to their commercial success with blinatumomab (Blincyto ® ) being the first product FDA-approved in 2014 [ 5 ]. Blinatumomab is a TRBA used for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory (R/R) B-ALL [ 5 ].…”

“…The clinical success of CD19-based treatment modalities eventually led to their commercial success with blinatumomab (Blincyto ® ) being the first product FDA-approved in 2014 [ 5 ]. Blinatumomab is a TRBA used for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory (R/R) B-ALL [ 5 ]. In 2020, two other anti-CD19 mAbs received FDA approval including inebilizumab (Uplizna ® ), a humanized mAb used for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD), and tafasitamab (Monjuvi ® ), which is a humanized cytolytic mAb used for the treatment of adult patients with R/R diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide (Revlimid ® ) [ 6 , 7 ].…”