23.01.2023 14:22:13
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Blueprint Medicines: FDA Grants Priority Review For Supplemental New Drug Application For AYVAKIT
(RTTNews) - Blueprint Medicines Corporation (BPMC) announced the FDA has accepted the company's supplemental new drug application for AYVAKIT for the treatment of adults with indolent systemic mastocytosis. The FDA granted priority review with an action date of May 22, 2023 under the PDUFA. The regulatory application is based on results from the global PIONEER trial.
AYVAKIT or avapritinib is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced systemic mastocytosis, including aggressive SM, SM with an associated hematological neoplasm and mast cell leukemia, and adults with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
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