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.
NEW YORK (GenomeWeb News) – Foundation Medicine and Ariad Pharmaceuticals today announced a deal aimed at the genomic profiling of patients enrolled in clinical trials for Ariad's investigational dual-inhibitor of ALK and EGFR for non-small cell lung cancer and other cancers.
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personalize treatment with Ariad Pharmaceuticals' leukemia drug ponatinib, announced this week that it has voluntarily withdrawn its premarket approval application for the test.
NEW YORK (GenomeWeb News) – MolecularMD and Ariad Pharmaceuticals today said that MolecularMD has withdrawn its premarket approval application to the US Food and Drug Administration for its BCR-ABL T315I Mutation Test.