GAVRETO
PeakNDAORALCAPSULEPriority Review
Approved
Dec 2020
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
GAVRETO by Blueprint Medicines is wild-type ret and oncogenic ret fusions (ccdc6- ret ) and mutations ( ret v804l, ret v804m and ret m918t) with half maximal inhibitory concentrations (ic 50s ) less than 0. Approved for older with advanced, metastatic ret fusion-positive thyroid cancer. First approved in 2020.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GAVRETO (pralsetinib) is an oral small-molecule RET inhibitor approved for advanced or metastatic RET fusion-positive thyroid cancer. It selectively targets wild-type RET and oncogenic RET fusions and mutations with sub-nanomolar potency, blocking hyperactivation of downstream signaling pathways that drive uncontrolled cell proliferation. The drug demonstrated anti-tumor activity and improved survival in preclinical models across multiple RET-driven malignancies.
$0.011BPart D
PeakProduct is at peak commercial maturity with modest Part D utilization (664 claims in 2023), suggesting a niche indication with stable but limited market penetration; team size likely focused on specialized oncology infrastructure.
Mechanism of Action
wild-type RET and oncogenic RET fusions (CCDC6- RET ) and mutations ( RET V804L, RET V804M and RET M918T) with half maximal inhibitory concentrations (IC 50s ) less than 0.5 nM. In purified enzyme assays, pralsetinib inhibited DDR1, TRKC, FLT3, JAK1-2, TRKA, VEGFR2, PDGFRB, and FGFR1 at higher…
Indications (2)
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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.