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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Ponatinib received accelerated approval for use in chronic myeloid leukemia and acute lymphoblastic leukemia patients who are resistant or intolerant to prior therapy with tyrosine kinase inhibitors.

Ariad’s Leukemia Drug Iclusig Sails Through FDA In Less Than 3 Months

Ponatinib received accelerated approval for use in chronic myeloid leukemia and acute lymphoblastic leukemia patients who are resistant or intolerant to prior therapy with tyrosine kinase inhibitors.

Teva’s Synribo: Salvage Therapy, But Not Personalized Medicine

Omacetaxine finds new life as a salvage treatment in chronic myeloid leukemia after failing to pass FDA muster for targeted therapy in patients with a particular genetic mutation. FDA allowed Teva to pool data from two open-label studies to secure approval in a third-line setting.

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