Drug updated on 9/4/2024
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).
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Summary
- Synribo (omacetaxine mepesuccinate (homoharringtonine)) is 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).
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- The pooled Overall Response Rate (ORR) for Homoharringtonine (HHT) in patients with Acute Myeloid Leukemia (AML) was 82% (CI, 77.9%-85.6%), with a Complete Response Rate (CRR) of 63.4% (CI, 58.8%-68%).
- In subgroup analyses for HHT, patients younger than 60 years demonstrated a significant overall response (OR, 1.63; CI, 1.33-2) and complete remission benefits (OR, 1.32; CI, 1.1-1.59). Newly diagnosed and relapsed/refractory patients also showed significant response benefits, with relapsed/refractory patients having an OR of 2.13 (CI, 1.38-3.29) for overall response and an OR of 1.81 (CI, 1.19-2.77) for complete remission.
- Decitabine in elderly AML patients was associated with higher Complete Response (CR) and Overall Response (OR) rates compared to low-dose cytarabine (CR: 2.60; 95% CI, 1.64-4.14, OR: 4.88; 95% CI, 1.98-12.04) and CAG/HAG regimens (CR: 2.53; 95% CI, 1.98-3.23, OR: 2.89; 95% CI, 2.24-3.73).
- Patients treated with Homoharringtonine (HHT) experienced reduced cardiotoxicity and lower relapse rates, with elderly patients showing a 76.6% reduction in relapse risk (OR, 0.23; CI, 0.09-0.63; I² = 0%; P = .004).
- For Decitabine in elderly AML patients, no significant differences in infection rates and early death rates were observed when compared to other treatments (P > .05).
- There is no population type or subgroup information available in the reviewed studies.
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 |
---|---|---|
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 |
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 |