Omacetaxine mepesuccinate (homoharringtonine)

(Synribo®)

Omacetaxine mepesuccinate (homoharringtonine)

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 3.5 mg)
Drug ClassAntineoplastics
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
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  • 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 TitleYearSource
Synribo (omacetaxine mepesuccinate) Prescribing Information.2021Teva Pharmaceuticals USA Inc., North Wales, PA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Chronic myeloid leukemia, version 2.2021.2020Journal of the National Comprehensive Cancer Network
Standard commercial drug formulary prior authorization guidelines - omacetaxine mepesuccinate. 2019Kaiser Permanente.org