AYVAKIT
PeakNDAORALTABLETPriority Review
Approved
Jan 2020
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
7/8 — Comprehensive
Priority Review
AYVAKIT by Blueprint Medicines is d816v, pdgfra and pdgfra d842 mutants as well as multiple kit exon 11, 11/17 and 17 mutants with half maximal inhibitory concentrations (ic 50s ) less than 25 nm in biochemical assays. Approved for metastatic gist harboring a platelet-derived growth factor receptor alpha (pdgfra) exon 18 mutation, including pdgfra d842v mutations [see ]. First approved in 2020.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AYVAKIT (avapritinib) is an oral tyrosine kinase inhibitor approved in January 2020 for the treatment of gastrointestinal stromal tumors (GIST) driven by PDGFRA mutations. It selectively targets PDGFRα kinase, offering a precision medicine approach for a defined patient subset with improved tolerability compared to broad-spectrum kinase inhibitors.
$55MPart D
Peak15.3 years to LOEAYVAKIT is in peak commercial phase with modest spending reflecting a niche indication; the Blueprint Medicines team is stabilized but not rapidly expanding.
Mechanism of Action
D816V, PDGFRA and PDGFRA D842 mutants as well as multiple KIT exon 11, 11/17 and 17 mutants with half maximal inhibitory concentrations (IC 50s ) less than 25 nM in biochemical assays. Certain mutations in PDGFRA and KIT can result in the autophosphorylation and constitutive activation of these…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.