FDA Approved Drugs » 2012
Medical Areas: Hematology | Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Teva Pharmaceutical
Approval Status: Approved October 2012
Treatment Area: chronic or accelerated phase chronic myeloid leukemia
Synribo (omacetaxine mepesuccinate) is a cephalotaxine ester. It is a protein synthesis inhibitor and is independent of direct Bcr-Abl binding.
Synribo is specifically approved for the treatment of adults with chronic or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.
Synribo is supplied as a solution for subcutaneous administration. The recommended initial dose of the drug is as follows: Induction Schedule: 1.25 mg/m2 administered subcutaneously twice daily for 14 consecutive days every 28 days, over a 28-day cycle. Cycles should be repeated every 28 days until patients achieve a hematologic response. Maintenance Dosing: 1.25 mg/m2 administered subcutaneously twice daily for 7 consecutive days every 28 days, over a 28-day cycle. Treatment should continue as long as patients are clinically benefiting from therapy.
FDA ApprovalThe FDA approval of Synribo was based on a combined cohort of adults with CML from two trials. The combined cohort consisted of subjects who had received two or more approved TKIs and had, at a minimum, documented evidence of resistance or intolerance to dasatinib and/or nilotinib. The subjects were treated with omacetaxine mepesuccinate at a dose of 1.25 mg/m2 administered subcutaneously twice daily for 14 consecutive days every 28 days (induction cycle). Responders were then treated with the same dose and twice daily schedule for 7 consecutive days every 28 days (maintenance cycle) for up to 24 months.Chronic Phase CMLA total of 76 subjects were included in the efficacy analysis. The efficacy endpoint was based on major cytogenetic response (MCyR). Fourteen subjects (18.4%) achieved MCyR; 7.9% achieved confirmed complete cytogenic response and 3.9% achieved confirmed partial cytogenic response. The mean time to MCyR onset was 3.5 months and the median duration of MCyR was 12.5 months.Accelerated Phase CMLA total of 35 subjects were included in the efficacy analysis. The efficacy endpoint was based on major cytogenetic response (MCyR) and MaHR (complete hematologic response [CHR] or no evidence of leukemia [NEL]. Five subjects (14.3%) achieved MaHR; 4 subjects (11.4%) CHR and one (2.9%) NEL. Zero subjects achieved MCyR. The mean time to response onset in the 5 subjects was 2.3 months and the median duration of MaHR was 4.7 months.
Adverse events associated with the use of Synribo may include, but are not limited to, the following:
Synribo (omacetaxine mepesuccinate) is a cephalotaxine ester. It is a protein synthesis inhibitor and is independent of direct Bcr-Abl binding. Omacetaxine mepesuccinate binds to the A-site cleft in the peptidyl-transferase center of the large ribosomal subunit from a strain of archaeabacteria. In vitro, omacetaxine mepesuccinate reduced protein levels of the Bcr-Abl oncoprotein and Mcl-1, an anti-apoptotic Bcl-2 family member.
Cortes J, Lipton JH, Rea D, Digumarti R, Chuah C, Nanda N, Benichou AC, Craig AR, Michallet M, Nicolini FE, Kantarjian H; on behalf of the Omacetaxine 202 Study Group Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation. Blood 2012 Sep 27;120(13):2573-2580
For additional information regarding Synribo or chronic or accelerated phase chronic myeloid leukemia, please visit the Synribo web page.
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