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FDA Grants Full Approval to Synribo (Omacetaxine Mepesuccinate) for CML

Two-year postmarketing commitment completed (February 13)

The FDA has granted full approval to Synribo (omacetaxine mepesuccinate, Teva Pharmaceutical Industries) for injection. The oncology product received accelerated approval in October 2012, with additional clinical trial data required to fulfill postmarketing requirements set forth by the FDA.

Synribo is indicated for adult patients with chronic-phase or accelerated-phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

Omacetaxine mepesuccinate is the first protein synthesis inhibitor for CML. While the drug’s mechanism of action is unclear, it has been shown to prevent the production of specific proteins (Bcr–Abl and Mcl-1) that are produced by cancerous CML cells and help drive the disease. As a protein synthesis inhibitor, the way omacetaxine mepesuccinate is believed to work does not directly depend on Bcr–Abl binding.

Source: Teva; February 13, 2014.

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