Difference between revisions of "Dasatinib (Sprycel)"

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==General information==
 
==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.<ref name="insert">[http://packageinserts.bms.com/pi/pi_sprycel.pdf Dasatinib (Sprycel) package insert]</ref><ref>[[Media:Dasatinib.pdf | Dasatinib (Sprycel) package insert (locally hosted backup)]]</ref><ref>[http://www.sprycel.com Sprycel maufacturer's website]</ref>
+
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.<ref name="insert">[http://packageinserts.bms.com/pi/pi_sprycel.pdf Dasatinib (Sprycel) package insert]</ref><ref>[[:File:Dasatinib.pdf | Dasatinib (Sprycel) package insert (locally hosted backup)]]</ref><ref>[http://www.sprycel.com Sprycel maufacturer's website]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
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==Diseases for which it is used==
 
==Diseases for which it is used==
−
*[[Chronic myelogenous leukemia]]
+
*[[Chronic myeloid leukemia]]
 
*[[B-cell_acute_lymphoblastic_leukemia,_Ph-positive|Ph+ B-cell ALL]]
 
*[[B-cell_acute_lymphoblastic_leukemia,_Ph-positive|Ph+ B-cell ALL]]
 
*[[Systemic mastocytosis]]
 
*[[Systemic mastocytosis]]
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==Patient drug information==
 
==Patient drug information==
 
*[http://packageinserts.bms.com/pi/pi_sprycel.pdf Dasatinib (Sprycel) package insert]<ref name="insert"></ref>  
 
*[http://packageinserts.bms.com/pi/pi_sprycel.pdf Dasatinib (Sprycel) package insert]<ref name="insert"></ref>  
−
*[http://chemocare.com/chemotherapy/drug-info/dasatinib.aspx Dasatinib (Sprycel) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/dasatinib.aspx Dasatinib (Sprycel) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/dasatinib.aspx Dasatinib (Sprycel) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/dasatinib.aspx Dasatinib (Sprycel) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/dasatinib-patient-drug-information Dasatinib (Sprycel) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/dasatinib-patient-drug-information Dasatinib (Sprycel) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/dasatinib-patient-drug-information Dasatinib (Sprycel) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/dasatinib-patient-drug-information Dasatinib (Sprycel) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*6/28/2006: Initial approval for the treatment of adults with:
+
===[[Chronic myeloid leukemia]]===
−
**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]].  
+
*2006-06-28: Initial accelerated approval for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase [[Chronic myeloid leukemia | chronic myeloid leukemia]] with resistance or intolerance to prior therapy including [[Imatinib (Gleevec) | imatinib]]. ''(Based on CA180-013)''
−
**[[Biomarkers#BCR-ABL1| Philadelphia chromosome-positive]] [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]] with resistance or intolerance to prior therapy.
+
**2009-05-21: Converted to regular approval for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase [[Chronic myeloid leukemia | chronic myeloid leukemia]] with resistance or intolerance to prior therapy including [[Imatinib (Gleevec) | imatinib]]. ''(Based on CA180-035)''
−
*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)''
+
*2007-11-08: New accelerated approval for the treatment of adults with chronic phase (CP) [[Chronic myeloid 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; based on CA180-034)''
−
*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)''
+
*2010-10-28: Accelerated approval for newly diagnosed adults with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive (Ph+)]] [[Chronic myeloid leukemia | chronic myeloid leukemia (CML)]] in chronic phase. ''(Approval expanded to the first-line setting; based on DASISION)''
−
*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)''
+
**2015-08-12: Converted to regular approval for newly diagnosed adults with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive (Ph+)]] [[Chronic myeloid leukemia | chronic myeloid leukemia (CML)]] in chronic phase. ''(Based on DASISION)''
 +
*2017-11-10: New indication for the treatment of pediatric patients with [[Biomarkers#BCR-ABL1|Philadelphia chromosome-positive]] [[Chronic myeloid leukemia |chronic myeloid leukemia]] in chronic phase. ''(Approval expanded to include the pediatric population; based on CA180-018 & CA180-226)''
  
 +
===[[B-cell acute lymphoblastic leukemia, Ph-positive|Ph+ ALL]]===
 +
*2006-06-28: 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. ''(Based on START-L)''
 +
*2018-12-21: Approved for pediatric patients 1 year of age and older with newly diagnosed [[Biomarkers#BCR-ABL1|Ph+]] [[:Category:Acute lymphoblastic leukemias|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 myeloid leukemia|chronic myelogenous leukemia]].
 +
*2009-01-21: Initial approval for the treatment of recurrent or refractory Philadelphia chromosome-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]].
 +
*2011-06-16: New additional indication and a new dosage for the treatment of [[Chronic myeloid leukemia|chronic myelocytic leukemia]].
 
==Also known as==
 
==Also known as==
 
*'''Code name:''' BMS-354825
 
*'''Code name:''' BMS-354825
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[[Category:Mutation-specific medications]]
 
[[Category:Mutation-specific medications]]
  
−
[[Category:Kinase inhibitors]]
+
 
 
[[Category:Bcr-Abl inhibitors]]
 
[[Category:Bcr-Abl inhibitors]]
 
[[Category:BTK inhibitors]]
 
[[Category:BTK inhibitors]]
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[[Category:B-cell acute lymphoblastic leukemia medications]]
 
[[Category:B-cell acute lymphoblastic leukemia medications]]
−
[[Category:Chronic myelogenous leukemia medications]]
+
[[Category:Chronic myeloid leukemia medications]]
 
[[Category:Systemic mastocytosis medications]]
 
[[Category:Systemic mastocytosis medications]]
  
 +
[[Category:EMA approved in 2006]]
 
[[Category:FDA approved in 2006]]
 
[[Category:FDA approved in 2006]]
 +
[[Category:Health Canada approved in 2007]]
 +
[[Category:PMDA approved in 2009]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 23:31, 2 September 2023

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

History of changes in FDA indication

Chronic myeloid leukemia

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

Also known as

  • Code name: BMS-354825
  • Brand name: Sprycel

References

  1. ↑ 1.0 1.1 1.2 Dasatinib (Sprycel) package insert
  2. ↑ Dasatinib (Sprycel) package insert (locally hosted backup)
  3. ↑ Sprycel maufacturer's website
  4. ↑ Dasatinib (Sprycel) patient drug information (Chemocare)
  5. ↑ Dasatinib (Sprycel) patient drug information (UpToDate)
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