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 Yesterday · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AYVAKIT (avapritinib) is an oral tyrosine kinase inhibitor approved by the FDA in January 2020 for the treatment of gastrointestinal stromal tumors (GIST) and other kinase-driven malignancies. It works by selectively inhibiting platelet-derived growth factor receptor alpha (PDGFRα) and other receptor tyrosine kinases, blocking aberrant signaling that drives tumor growth. The drug represents a targeted precision medicine approach for patients with specific genetic mutations.
$55MPart D
Peak15.6 years to LOEAYVAKIT is in peak commercial phase with modest Medicare spending; Blueprint's focused commercial strategy suggests a specialized, lean-to-mid-sized team optimized for precision oncology markets.
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.