Dasatinib (Sprycel)

==General information==
Class/mechanism: Tyrosine kinase inhibitor of BCR-ABL, the SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Binds to multiple conformations of the ABL kinase.Dasatinib (Sprycel) package insert Dasatinib (Sprycel) package insert (locally hosted backup)Sprycel maufacturer's website
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Diseases for which it is used==
*Chronic myeloid leukemia
*Ph+ B-cell ALL
*Systemic mastocytosis
==Patient drug information==
*Dasatinib (Sprycel) package insert 
*Dasatinib (Sprycel) patient drug information (Chemocare)Dasatinib (Sprycel) patient drug information (Chemocare)
*Dasatinib (Sprycel) patient drug information (UpToDate)Dasatinib (Sprycel) patient drug information (UpToDate)
==History of changes in FDA indication==
===Chronic myeloid leukemia===
*2006-06-28: Initial accelerated approval for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib. (Based on CA180-013)
**2009-05-21: Converted to regular approval for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib. (Based on CA180-035)
*2007-11-08: New accelerated approval for the treatment of adults with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy, including imatinib mesylate. The new dosing regimen is 100 mg taken orally once daily. (New dosing instruction; based on CA180-034)
*2010-10-28: Accelerated approval for newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (Approval expanded to the first-line setting; based on DASISION)
**2015-08-12: Converted to regular approval for newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (Based on DASISION)
*2017-11-10: New indication for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. (Approval expanded to include the pediatric population; based on CA180-018 & CA180-226)
===Ph+ ALL===
*2006-06-28: Initial approval for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy. (Based on START-L)
*2018-12-21: Approved for pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (Based on COG AALL1122)
==History of changes in EMA indication==
*2006-11-20: Initial authorization
==History of changes in Health Canada indication==
*2007-03-26: Initial notice of compliance with conditions
*2009-11-19: Conditions were met
==History of changes in PMDA indication==
*2009-01-21: Initial approval for the treatment of imatinib-resistant chronic myelogenous leukemia.
*2009-01-21: Initial approval for the treatment of recurrent or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.
*2011-06-16: New additional indication and a new dosage for the treatment of chronic myelocytic leukemia.
==Also known as==
*Code name: BMS-354825
*Brand name: Dasacine, Dasakast, Dasamed, Dasatab, Dasatib, Dasashil, DasaMyl, Dashori, Dasanat, Dyronib, Spnib, Sprycel, Sprymia
==References==
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:Bcr-Abl inhibitors
Category:BTK inhibitors
Category:KIT inhibitors
Category:PDGFR inhibitors
Category:SRC inhibitors
Category:SYK inhibitors
Category:B-cell acute lymphoblastic leukemia medications
Category:Chronic myeloid leukemia medications
Category:Systemic mastocytosis medications
Category:EMA approved in 2006
Category:FDA approved in 2006
Category:Health Canada approved in 2007
Category:PMDA approved in 2009
Category:WHO Essential Cancer Medicine