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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GAVRETO (pralsetinib) is an oral RET-selective tyrosine kinase inhibitor approved in December 2020 for treating adults with advanced or metastatic RET fusion-positive thyroid cancer. The drug potently inhibits wild-type RET and oncogenic RET fusions (including CCDC6-RET) and activating mutations (RET V804L, V804M, M918T) at sub-nanomolar concentrations. Pralsetinib demonstrates approximately 14-40 fold selectivity for RET over off-target kinases like VEGFR2 and FGFR2 in cellular assays, reducing uncontrolled cell proliferation driven by RET hyperactivation. It represents a precision oncology approach targeting a molecularly defined patient population with RET-driven malignancies.
$0.0BPart D
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.