What conditions is Ayvakit (avapritinib) approved to treat?
Ayvakit (avapritinib) is an oral targeted therapy approved for specific rare blood-cancer and gastrointestinal stromal tumor (GIST) indications. The exact labeled indications depend on the country and the current regulatory updates.
Which Ayvakit indications are most commonly cited in drug labeling?
In practice, Ayvakit’s most widely referenced indications include:
- Certain advanced forms of GIST where the tumor has a specific mutation (commonly PDGFRA exon 18, including D842V) and after prior therapy has been tried (when required by the label).
- Advanced systemic mastocytosis, including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL), based on the current labeling framework used by regulators.
How do mutations affect whether Ayvakit is used?
For GIST, Ayvakit use depends on identifying the relevant mutation (especially PDGFRA exon 18 alterations). For mastocytosis, the indication is tied to the subtype of systemic mast cell disease rather than a single mutation test in the way GIST commonly is.
Does Ayvakit’s indication change with safety warnings or dose adjustments?
Ayvakit has safety communications tied to patient selection and dosing in clinical practice, which can affect how and when clinicians prescribe it. Label language may include guidance that narrows use to certain patient groups and schedules dose adjustments based on tolerance.
Want the exact indication text for your country?
If you tell me which country’s label you want (US, EU, UK, etc.), I can provide the exact approved indication wording and any required eligibility criteria (mutation type, prior-therapy requirements, and the specific disease subtypes).