Blueprint Medicines submits new drug application to FDA
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, Blueprint Medicines(http:// announcedthat it had submitted anew drug(http://application (NDA) for Avapritinib to the u.SFDA(http://for the treatment of adult patients with PDGFRA exosome 18 mutations in gastrointestinal interlocosense (GIST) or as a fourth-line GIST therapyAvapritinibAvapritinib is a highly selective powerful KIT and PDGFRA inhibitorThe company also asked the FDA to use priority reviews to process the applicationIf qualified for priority review, the review time for this new drug application will be reduced to six monthsAvapritinib is an oral precision therapy that strongly and specifically inhibits protein kinases from KIT and PDGFRA gene mutationsThis is a type 1 inhibitor that targets kinase activation of the conformationAvapritinib is able to inhibit a variety of protein kinases that carry mutations in the KIT and PDGFRA genesThis therapy has been approved by the FDA as a breakthrough therapy for treatment of patients with unable to excision or metastatic GIST with a PDGFR alpha D842V mutation Recently, at the annual meeting of the American Society of Clinical Oncology, Blueprint Medicines presented clinical trial (http:// data that supports the application for a new drug the objective remission rate (ORR) reached 86% in patients with GIST with 18 mutations in PDGFRA exons In patients treated with GIST as a four-line therapy, THE ORR reached 22% and the median remission duration (DOR) was 10.2 months
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