Avapritinib

(Ayvakit®)

Ayvakit®

Drug updated on 9/4/2024

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).

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Summary
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  • Ayvakit (avapritinib) 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; the treatment of adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL); and the treatment of adult patients with indolent systemic mastocytosis (ISM).
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Overall Survival (OS): Avapritinib was associated with a 56% reduction in the hazard of death compared to midostaurin, as indicated by an adjusted hazard ratio of 0.44 (95% CI: 0.25-0.76) in patients with advanced systemic mastocytosis.
  • Overall Response Rate (ORR): Avapritinib demonstrated significantly higher effectiveness in achieving an overall response, with an adjusted odds ratio of 4.06 (95% CI: 3.09-5.33) compared to midostaurin.
  • Complete Remission (CR): Avapritinib showed a much higher likelihood of achieving complete remission, with an adjusted odds ratio of 9.56 (95% CI: 0.97-93.81) compared to midostaurin, though the wide confidence interval suggests considerable variability.
  • There is no safety information available in the reviewed studies.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines