Avapritinib

(Ayvakit®)

Avapritinib

Drug updated on 5/17/2024

Dosage FormTablets (oral; 25 mg, 50 mg, 100 mg, 200 mg and 300 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
  • Indicated for the treatment of adult patients with advanced systematic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL).
  • Indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM).

Latest News

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Summary
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  • Avapritinib (Ayvakit) is indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. It is also used to treat adult patients with advanced systemic mastocytosis (AdvSM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia.
  • The information was derived from one systematic review/meta-analysis study that compared avapritinib and midostaurin in terms of effectiveness and safety for patients with AdvSM.
  • Compared to midostaurin, avapritinib showed significant improvement in overall survival rate, indicating more than a 50% reduction in the risk of death.
  • Avapritinib also demonstrated superior effectiveness over midostaurin regarding overall response rate and complete remission rates; it increased the odds of response fourfold and suggested higher chances of complete remission.
  • While detailed safety information or comprehensive subgroup analyses were not provided within the study reviewed, improved outcomes associated with avapritinib suggest potential therapeutic benefits over midostaurin for AdvSM patients.
  • No specific population types or subgroup considerations were mentioned within the study; future research could provide insights into how different populations might benefit variably from avapritinib as compared to midostaurin.

Product Monograph / Prescribing Information

Document TitleYearSource
Ayvakit (avapritinib) Prescribing Information.2023Blueprint Medicines Corporation., Cambridge, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines