SPRYCEL
LOE ApproachingNDAORALTABLETPriority Review
Approved
Jun 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
Priority Review
SPRYCEL by Bristol Myers Squibb is dasatinib, at nanomolar concentrations, inhibits the following kinases: bcr-abl, src family (src, lck, yes, fyn), c-kit, epha2, and pdgfrβ. Approved for older with • ph+ cml in chronic phase, • newly diagnosed adults with philadelphia chromosome-positive (ph+) chronic myeloid leukemia (cml) in chronic phase. First approved in 2006.
Drug data last refreshed 3d ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPRYCEL (dasatinib) is an oral small-molecule tyrosine kinase inhibitor approved in June 2006 for treating newly diagnosed and imatinib-resistant Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Dasatinib inhibits BCR-ABL and multiple SRC family kinases at nanomolar concentrations, enabling activity against both imatinib-sensitive and resistant disease including BCR-ABL kinase domain mutations. The drug overcomes resistance mechanisms involving alternate SRC family signaling and multi-drug resistance, positioning it as a critical option for patients with resistant or intolerant CML.
$0.5BPart D
Mechanism of Action
Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro , dasatinib was active in leukemic cell lines…
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.