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T315I

Europe's Rx Risk Assessment Group Recommends Keeping Iclusig Indications Unchanged
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Originally published Oct. 14.

Ariad's Iclusig to Relaunch in Advanced T315I-Mutated Leukemia or Third-Line Patients
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Originally published Jan. 10. Ariad Pharmaceuticals is planning to resume marketing its leukemia drug Iclusig (ponatinib) in mid-January, with a narrower indication for a genetically-defined population and for those with unmet medical needs.

Ariad Stops Iclusig Sales Due to Serious AEs; Would a CDx Have Changed Risk/Benefit Profile?
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This article has been updated with a statement from the FDA and to clarify that MolecularMD withdrew its PMA for the T315I companion test after the FDA deemed it not necessary to support Iclusig's administration. Originally published Nov. 1.

FDA Approves Ariad's Iclusig for Molecularly Defined, TKI-Resistant Leukemias
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Originally published Dec. 17. The US Food and Drug Administration this week granted accelerated approval for Ariad Pharmaceuticals' Iclusig as a treatment for two types of rare, genetically characterized leukemias.

MolecularMD Pulls PMA After FDA Says Companion Dx Not Needed to Establish Ponatinib Efficacy, Safety
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MolecularMD, a diagnostics firm that was developing a companion test to personalize treatment with Ariad Pharmaceuticals' leukemia drug ponatinib, announced this week that it has voluntarily withdrawn its premarket approval application for the test.
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The Scan

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