BPMC - Blueprint Medicines files US application for expanded use of Ayvakit

Blueprint Medicines (BPMC) has submitted a supplemental new drug application to the FDA seeking approval for Ayvakit (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis ((SM)), a rare disorder characterized by the uncontrolled proliferation and activation of mast cells, which, when triggered, leads to a range of symptoms like rapid heartbeat, lightheadedness and facial flushing. It is driven by a mutation in the KIT gene called D816V.AYVAKIT is a selective inhibitor of D816V mutant KIT.Blueprint Medicines requested priority review for this application, which, if granted, could result in a six-month review process.The FDA approved Ayvakit for the treatment of unresectable/metastatic gastrointestinal stromal tumor harboring a platelet-derived growth factor receptor alpha exon 18 mutation.

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Blueprint Medicines files US application for expanded use of Ayvakit