Omacetaxine mepesuccinate

(Synribo®)

Synribo®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 3.5 mg)
Drug ClassAntineoplastic agents
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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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Omacetaxine mepesuccinate (Synribo) demonstrated a major molecular response (MMR) rate of 19.2% and a complete cytogenetic response (CCyR) rate of 16.1% at 6 months in adult patients with chronic phase-chronic myeloid leukemia (CP-CML) who have received ≥ 2 prior TKIs (ATP-competitive tyrosine kinase inhibitors).
  • Ponatinib exhibited an MMR rate ranging from 19.0% to 66.7% and a CCyR rate from 21.4% to 64.8% at 6 months, while asciminib showed an MMR rate of 23.3% to 25.5% and a CCyR rate of 38.7% to 40.8% at the same time point. Bosutinib had an MMR rate of 13.2% and CCyR rates between 18% and 24.2% at 6 months.
  • The studies indicate that the findings focus on patients resistant or intolerant to multiple lines of TKI therapy, underscoring the need for additional treatment strategies in this subgroup.
  • There is no safety information available in the reviewed studies.
  • The Population Types and Subgroup Considerations section highlights that the focus is on adult patients with chronic phase-chronic myeloid leukemia (CP-CML) who have received ≥ 2 prior TKIs, specifically addressing those who are resistant or intolerant to multiple lines of TKI therapy, indicating a subgroup that may particularly benefit from novel treatment options, including omacetaxine.

Product Monograph / Prescribing Information

Document TitleYearSource
Synribo (omacetaxine mepesuccinate) Prescribing Information.2021Teva Pharmaceuticals USA, Inc., Parsippany, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Chronic Myeloid Leukemia, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology2024Journal of the National Comprehensive Cancer Network
Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology2020Journal of the National Comprehensive Cancer Network