Ayvakit® is the commercial brand name of Avapritinib Tablets, developed by Blueprint Medicines. It is an oral highly selective inhibitor of KIT and PDGFRα kinases. It potently suppresses mutated KIT and PDGFRα signaling pathways, exerting anti-tumor activity against gastrointestinal stromal tumors (GIST) and systemic mastocytosis driven by relevant gene mutations.
Main Indications
Treatment of unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring PDGFRA exon 18 mutations, including PDGFRA D842V mutation, in adult patients;
Treatment of adult patients with advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia.
Clinical Research
Global multicenter phase I/II pivotal trials fully validated its durable tumor regression efficacy for PDGFRA exon 18-mutant GIST patients with limited prior treatment options;
Head-to-head comparative registration trials confirmed superior objective response rate versus conventional tyrosine kinase inhibitors for refractory mutant GIST;
Long-term observational cohort studies demonstrated sustained control of mast cell activation-related symptoms and reduced disease progression risk in advanced systemic mastocytosis patients;
Dose-finding research verified balanced anti-tumor efficacy and intracranial safety profile of the 100mg once-daily oral maintenance regimen;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for local mutant GIST and AdvSM patient populations.
Common Side Effects
Common mild adverse reactions: Edema, nausea, fatigue, vomiting, diarrhea, periorbital swelling and cognitive impairment;
Laboratory abnormalities: Transient mild anemia, thrombocytopenia and elevated liver transaminases;
Severe but uncommon risks: Intracranial hemorrhage, severe cognitive disorders, severe gastrointestinal hemorrhage and severe hypersensitivity rash.
Approval Status in China
Original drug Ayvakit® (Chinese brand: Taijihua) was officially approved for marketing in China in 2021, with the specification of 100mg per tablet, 30 tablets per box. It is currently a prescription targeted anti-tumor drug included in China’s Category B medical insurance catalogue.
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