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T315I

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.

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.

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, 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personalize treatment with Ariad Pharmaceuticals' leukemia drug ponatinib, announced this week that it has voluntarily withdrawn its premarket approval application for the test.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 MolecularMD companion diagnostic test is being developed to identify CML and Ph+ ALL patients who have the T315I mutation," Ariad said in a statement, adding that a companion diagnostic test "is not necessary to support the broader potential use of ponatinib," since many other mutations contribute to patients' resistance to BCR-ABL inhibitors.

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