The Medical Letter on Drugs and Therapeutics
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In Brief: Ponatinib (Iclusig) Marketing and Sales Suspended

The FDA recently issued a Drug Safety Communication saying that it had asked the manufacturer of ponatinib (Iclusig – Ariad) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels.1 Ponatinib is a tyrosine kinase inhibitor that was granted accelerated approval by the FDA in December 2012 for treatment of chronic-, accelerated, or blast-phase chronic myeloid leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) resistant to (or the patients were intolerant to) prior tyrosine kinase inhibitor therapy. It is the first tyrosine kinase inhibitor that is effective against the T315I mutation, which is present in up to 20% of patients with treatment-resistant CML.2

The labeling of Iclusig includes a warning about the risk of ... more      

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