Drug updated on 4/15/2024
| Dosage Form | Injection (subcutaneous; 3.5 mg) |
| Drug Class | Antineoplastics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).
Summary
- Omacetaxine mepesuccinate (Synribo) is approved for use in adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) who have shown resistance and/or intolerance to two or more tyrosine kinase inhibitors. It has demonstrated significant effectiveness in acute myeloid leukemia (AML), with an 82% overall response rate and a 63.4% complete remission rate, especially in newly diagnosed patients or those under 60 years.
- Four systematic reviews/meta-analyses were conducted to assess the efficacy and safety profile of Synribo.
- In comparison with decitabine, both medications are beneficial in particular patient groups: younger, newly diagnosed AML patients show a favorable response to Synribo, whereas older AML patients have a better response to decitabine. Synribo's less cardiotoxic profile offers a safety advantage over other medications.
- Subgroup analysis indicates that elderly AML patients intolerant to other treatments experienced a 76.6% reduced risk of relapse when treated with Synribo. Decitabine also shows significant effectiveness in older AML patients, offering a favorable comparison against low-dose alternatives such as cytarabine.
- The treatment landscape for CML presents challenges due to resistance and/or intolerance to tyrosine kinase inhibitors, highlighting the importance of novel therapeutic options like Synribo, especially for those resistant or intolerant to multiple tyrosine kinase inhibitors. However, the studies reviewed provide limited comparative data, emphasizing the need for alternative strategies rather than direct comparisons.
- Patient subgroups are critical in deciding between Omacetaxine mepesuccinate (Synribo) and decitabine. The former is particularly beneficial for the younger, newly diagnosed, or under-60 age group, while the latter is effective among older patients, underscoring the relevance of considering patient demographics in treatment decisions.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Synribo (omacetaxine mepesuccinate) Prescribing Information. | 2021 | Teva Pharmaceuticals USA Inc., North Wales, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of homoharringtonine for the treatment of acute myeloid leukemia: a meta-analysis. | 2021 | Clinical Lymphoma, Myeloma and Leukemia |
| Third-line therapy for chronic myeloid leukemia: current status and future directions. | 2021 | Journal of Hematology & Oncology |
| Novel therapeutic approaches in chronic myeloid leukemia. | 2020 | Leukemia Research |
| Decitabine compared with conventional regimens in older patients with acute myeloid leukemia: a meta-analysis | 2019 | Clinical Lymphoma, Myeloma and Leukemia |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Chronic myeloid leukemia, version 2.2021. | 2020 | Journal of the National Comprehensive Cancer Network |
| Standard commercial drug formulary prior authorization guidelines - omacetaxine mepesuccinate. | 2019 | Kaiser Permanente.org |