Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous: 35 mcg) |
| Drug Class | CD19-directed CD3 T-cell engagers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
- Indicated for the treatment of adults and pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Summary
- Blinatumomab (Blincyto) is indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1%, and for those with relapsed or refractory ALL.
- Fifteen studies provide a comprehensive comparison between blinatumomab and alternative treatments, focusing on safety and efficacy for both pediatric and adult populations with ALL.
- Anti-CD19 CAR T-cell therapy showed superior efficacy over Blincyto in relapsed/refractory acute lymphocytic leukemia. However, Blincyto was associated with lower rates of severe hematological toxicity and cytokine release syndrome (CRS), indicating a better safety profile.
- In pediatric patients, Blincyto has demonstrated potent therapeutic efficacy with limited adverse effects compared to other available treatments for this population group suffering from relapsed/refractory B-ALL.
- When comparing salvage therapies, such as standard chemotherapy and other immunotherapies like inotuzumab ozogamicin & CD19/CD22 dual CAR T-cells, blinatumomab is generally more favorable compared to conventional chemotherapy due to its safer profile marked by fewer serious adverse events, although it is less effective than CAR-T cell therapies.
- Despite concerns over the long-term effectiveness and access equity related to CAR-T cell therapy, it is considered a cost-effective option based on health-economic evidence. Blinatumomab is positioned as the next best treatment option following it, especially for r/r ALL cases.
- Blinatumomab also plays an important role before allogeneic hematopoietic stem cell transplantation, where achieving an MRD-negative state is pivotal. This can be effectively achieved using blinatumomab, making it an integral part of the therapeutic arsenal against ALL.
- While there are potential risks associated with Blincyto, such as CRS and neurologic events, it poses a lower risk of significant adverse events compared to traditional chemotherapy in pediatric patients.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Blincyto (blinatumomab) Prescribing Information. | 2024 | Amgen Inc., Thousand Oaks, California |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| ESMO clinical practice guideline interim update on the use of targeted therapy in acute lymphoblastic leukaemia. | 2023 | Annals of Oncology |
| Acute lymphoblastic leukemia in adults. | 2022 | Alberta Health Services |
| Acute lymphoblastic leukemia, version 2.2021, NCCN clinical practice guidelines in oncology. | 2021 | Journal of the National Comprehensive Cancer Network |
| The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia. | 2020 | Journal for ImmunoTherapy of Cancer |