Posted on February 21st, 2014 by
The U.S. Food and Drug Administration (FDA) has granted full approval of SYNRIBO® (omacetaxine mepesuccinate) for injection. SYNRIBO is indicated for adult patients with chronic phase (CP +0.28%, news) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). SYNRIBO® 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).
The original approval of SYNRIBO® was based on an analysis of combined data subsets from two Phase 2, open-label, multicenter studies. The pooled analysis included patients who had received 2 or more approved TKIs and, at a minimum, had evidence of resistance or intolerance to dasatinib and/or nilotinib. 47% of CP patients and 63% of AP patients had failed treatment with imatinib, dasatinib, and nilotinib. The majority of patients had also received other treatments including hydroxyurea, interferon, and cytarabine.
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