Teva’s Synribo Clears FDA For Third-Line Chronic Myeloid Leukemia

Omacetaxine, which was originally submitted by ChemGenex as Omapro, demonstrated response rates of 14% to 18% in patients who had failed two or more tyrosine kinase inhibitors. It enters a crowded space that is likely to add a new member, Ariad’s ponatinib, in the coming months.

FDA approval of Teva Pharmaceutical Industries Ltd.’s Synribo (omacetaxine mepesuccinate) is a validation of the chronic myeloid leukemia drug’s efficacy in a salvage setting, but its commercial prospects may be limited by a narrow population, modest efficacy and an increasingly crowded therapeutic space that is expected to grow even more so in the coming months.

The agency granted accelerated approval to Synribo, a protein synthesis inhibitor that is administered subcutaneously, on Oct. 26 for treatment...

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