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Ayvakit FDA Approval History

Last updated by Judith Stewart, BPharm on June 28, 2021.

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, Systemic Mastocytosis

Ayvakit (avapritinib) is a kinase inhibitor for the treatment of PDGFRα exon 18 mutant gastrointestinal stromal tumors (GIST), and advanced systemic mastocytosis (AdvSM).

  • Ayvakit is an oral tablet administered once daily on an empty stomach, at least 1 hour before or 2 hours after a meal.
  • Ayvakit can cause serious side effects including intracranial hemorrhage, cognitive symptoms, and harm to a newborn baby. Common adverse reactions in patients with GIST include edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash, and dizziness. Common adverse reactions in patients with AdvSM include edema, diarrhea, nausea, and fatigue/asthenia.

Development Timeline for Ayvakit

DateArticle
Jun 16, 2021Approval  FDA Approves Blueprint Medicines' Ayvakit (avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis
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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