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.
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), 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 (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: Sprycel