Drug updated on 12/11/2024
Dosage Form | Injection (subcutaneous; 3.5 mg) |
Drug Class | Antineoplastic 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).
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Synribo (omacetaxine mepesuccinate) Prescribing Information. | 2021 | Teva Pharmaceuticals USA, Inc., Parsippany, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Therapy for patients with chronic phase-chronic myeloid leukemia previously treated with ⩾2 tyrosine kinase inhibitors: a systematic literature review | 2023 | Therapeutic Advances in Hematology |
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 2.2024, NCCN Clinical Practice Guidelines in Oncology | 2024 | Journal of the National Comprehensive Cancer Network |
Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology | 2020 | Journal of the National Comprehensive Cancer Network |