Difference between revisions of "Dasatinib (Sprycel)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
− | *6/28/2006: Initial approval for the treatment of adults with | + | ===[[Chronic myelogenous leukemia]]=== |
− | + | *6/28/2006: Initial approval for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase [[Chronic myelogenous leukemia | chronic myeloid leukemia]] with resistance or intolerance to prior therapy including [[Imatinib (Gleevec) | imatinib]]. | |
− | |||
*11/8/2007: New accelerated approval for the treatment of adults with chronic phase (CP) [[Chronic myelogenous leukemia |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)'' | *11/8/2007: New accelerated approval for the treatment of adults with chronic phase (CP) [[Chronic myelogenous leukemia |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)'' | ||
*10/28/2010: New indication for newly diagnosed adults with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive (Ph+)]] [[Chronic myelogenous leukemia | chronic myeloid leukemia (CML)]] in chronic phase. ''(Approval expanded to the first-line setting)'' | *10/28/2010: New indication for newly diagnosed adults with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive (Ph+)]] [[Chronic myelogenous leukemia | chronic myeloid leukemia (CML)]] in chronic phase. ''(Approval expanded to the first-line setting)'' | ||
*11/10/2017: New indication for the treatment of pediatric patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive]] [[Chronic myelogenous leukemia |chronic myeloid leukemia]] in chronic phase. ''(Approval expanded to include the pediatric population)'' | *11/10/2017: New indication for the treatment of pediatric patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive]] [[Chronic myelogenous leukemia |chronic myeloid leukemia]] in chronic phase. ''(Approval expanded to include the pediatric population)'' | ||
+ | |||
+ | ===[[B-cell acute lymphoblastic leukemia, Ph-positive|Ph+ ALL]]=== | ||
+ | *6/28/2006: Initial approval for the treatment of adults with [[Biomarkers#BCR-ABL1| Philadelphia chromosome-positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] with resistance or intolerance to prior therapy. | ||
==Also known as== | ==Also known as== |
Revision as of 01:50, 30 November 2020
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.[1][2][3]
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.[1]
Diseases for which it is used
Patient drug information
- Dasatinib (Sprycel) package insert[1]
- Dasatinib (Sprycel) patient drug information (Chemocare)[4]
- Dasatinib (Sprycel) patient drug information (UpToDate)[5]
History of changes in FDA indication
Chronic myelogenous leukemia
- 6/28/2006: Initial 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.
- 11/8/2007: 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)
- 10/28/2010: New indication for newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (Approval expanded to the first-line setting)
- 11/10/2017: 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)
Ph+ ALL
- 6/28/2006: Initial approval for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
Also known as
- Code name: BMS-354825
- Brand name: Sprycel
References
Categories:
- Drugs
- Oral medications
- Mutation-specific medications
- Bcr-Abl inhibitors
- BTK inhibitors
- KIT inhibitors
- PDGFR inhibitors
- SRC inhibitors
- SYK inhibitors
- B-cell acute lymphoblastic leukemia medications
- Chronic myelogenous leukemia medications
- Systemic mastocytosis medications
- FDA approved in 2006
- WHO Essential Cancer Medicine