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Ayvakit FDA Approval History

FDA Approved: Yes (First approved January 9, 2020)
Brand name: Ayvakit
Generic name: avapritinib
Dosage form: Tablets
Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor

Ayvakit (avapritinib) is a kinase inhibitor for the treatment of PDGFRα exon 18 mutant gastrointestinal stromal tumors (GIST).

  • Ayvakit is a tablet taken once daily on an empty stomach.
  • Ayvakit can cause serious side effects including bleeding inside the skull, effects on the central nervous system, and harm to a newborn baby. Common side effects of include swelling, nausea, tiredness, trouble thinking, vomiting, decreased appetite, diarrhea, hair color change, increased tear secretion, abdominal pain, constipation, rash and dizziness.

Development Timeline for Ayvakit

DateArticle
Jan  9, 2020Approval FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor
Oct 28, 2019Blueprint Medicines Announces FDA Intent to Split Avapritinib New Drug Application into Separate Submissions for PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
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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