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Avapritinib Approval Status

FDA Approved: No
Generic name: avapritinib
Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor

Avapritinib (formerly known as BLU-285) is a potent and highly selective KIT and PDGFRα inhibitor in development for the treatment of PDGFRα Exon 18 mutant gastrointestinal stromal tumors (GIST) and fourth-line GIST.

Development Status and FDA Approval Process for avapritinib

DateArticle
Aug  7, 2019Blueprint Medicines Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
Jun 14, 2019Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
Dec  4, 2018Blueprint Medicines Announces Updated Results from Ongoing EXPLORER Clinical Trial of Avapritinib Demonstrating Broad Clinical Activity and Significant Symptom Reductions in Patients with Systemic Mastocytosis
Nov 15, 2018Blueprint Medicines Announces Updated NAVIGATOR Trial Results in Patients with Advanced Gastrointestinal Stromal Tumors Supporting Development of Avapritinib Across All Lines of Therapy
Jun 21, 2018Blueprint Medicines Initiates VOYAGER Phase 3 Clinical Trial of Avapritinib in Patients with Advanced Gastrointestinal Stromal Tumors
Dec 20, 2017Blueprint Medicines Announces New Data from Ongoing Phase 1 Clinical Trial of Avapritinib (BLU-285) in Patients with Advanced Systemic Mastocytosis Showing Evidence of Strong Clinical Activity

Further information

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