About
AYVAKYT

(avapritinib)

Indications1

Indolent Systemic Mastocytosis (ISM)

AYVAKYT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment

Advanced Systemic Mastocytosis (SM)

AYVAKYT® (avapritinib) is indicated as monotherapy for the treatment of adult patients with aggressive SM (ASM), SM with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy

AYVAKYT is a tyrosine kinase inhibitor designed for potent and selective inhibition of KIT D816V1–3

Drawing of a clipboard with the AYVAKYT logo

Mechanism of disease

Both ISM4,5 and Advanced SM6–8 are driven by KIT D816V mutation in ~95% of cases; however, until recently, there were no treatment options that selectively targeted this mutation2,3

Targeted mechanism of action

  • AYVAKYT is a tyrosine kinase inhibitor that potently and selectively inhibits the autophosphorylation of KIT D816V, with an IC50 of 0.27 nM in in-vitro biochemical assays1,6
  • AYVAKYT inhibits constitutive KIT activation7
  • AYVAKYT inhibits mast cell proliferation and activation7
Illustration of AYVAKYT
Icon of a magnifying glass

Learn about the AYVAKYT key registration trials (PIONEER and PATHFINDER)

Clinical Trials

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the product SmPC for how to report adverse reactions.

References

  1. AYVAKYT® (avapritinib). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/ayvakyt-epar-product-information_en.pdf. Accessed February 2024.
  2. Gotlib J, et al. NEJM Evid. 2023;2(6):EVIDoa2200339.
  3. Gotlib J, et al. Nat Med. 2021;27(12):2192–2199.
  4. Muñoz-González JI, et al. Blood. 2019;134(5):456–468.
  5. Ungerstedt J, et al. Cancers. 2022;14(16):3942.
  6. Evans EK, et al. Sci Transl Med. 2017;9(414):eaao1690.
  7. Verstovsek S. Eur J Haematol. 2013;90(2):89–98.
  8. Garcia-Montero AC, et al. Blood. 2006;108(7):2366−2372.

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