Posted by Michael Wonder on 07 Aug 2019
Blueprint Medicines announces FDA acceptance of new drug application for avapritinib for the treatment of PDGFRA exon 18 mutant GIST and fourth-line GIST
7 August 2019 - FDA grants priority review and sets PDUFA date for 14 February 2020.
Blueprint Medicines Corporation today announced that the U.S. FDA has accepted the company's new drug application for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumours (GIST), regardless of prior therapy, and fourth-line GIST.
The FDA granted priority review and set an action date of 14 February 2020 under the Prescription Drug User Fee Act. At this time, the FDA is not planning to hold an advisory committee meeting to discuss this application.
Avapritinib, an investigational therapy, is a potent and highly selective KIT and PDGFRA inhibitor for patients with advanced GIST.
