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FDA Grants Priority Review to Avapritinib for GIST

Gina Columbus
Published: Wednesday, Aug 07, 2019

The FDA has granted a priority review designation to a new drug application (NDA) for avapritinib for the treatment of adult patients with PDGFRA exon 18–mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, as well as for patients with GIST in the fourth-line setting.1

The ongoing, international, open-label, randomized phase III VOYAGER trial (NCT03465722) is evaluating the safety and efficacy of avapritinib versus regorafenib (Stivarga) in patients with third- or fourth-line advanced GIST. 

References

  1. Blueprint Medicines Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST. Blueprint Medicines Corporation. Published August 7, 2019. https://bit.ly/2Kn4Ply. Accessed August 7, 2019.
  2. Heinrich M, Jones RL, von Mehren M, et al. Clinical activity of avapritinib in ≥4th line (4L+) and PDGFRA exon 18 gastrointestinal stromal tumors (GIST). J Clin Oncol. 2019;37 (suppl; abstr 11022).

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