Difference between revisions of "Sunitinib (Sutent)"

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==General information==
 
==General information==
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Class/mechanism: Tyrosine kinase inhibitor, inhibits multiple tyrosine kinases, including: vascular endothelial growth factor receptor (VEGFR1, VEGFR2 and VEGFR3), platelet-derived growth factor receptors (PDGFRα and PDGFRβ), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and RET.  Inhibition of these kinases disrupts angiogenesis, tumor cell signaling, and induces apoptosis.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=607 Sunitinib (Sutent) package insert]</ref><ref>[[Media:Sunitinib.pdf | Sunitinib (Sutent) package insert (locally hosted backup)]]</ref><ref>[http://sutent.com/ Sutent manufacturer's website]</ref>
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Class/mechanism: Tyrosine kinase inhibitor, inhibits multiple tyrosine kinases, including: vascular endothelial growth factor receptor (VEGFR1, VEGFR2 and VEGFR3), platelet-derived growth factor receptors (PDGFRα and PDGFRβ), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and RET.  Inhibition of these kinases disrupts angiogenesis, tumor cell signaling, and induces apoptosis.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=607 Sunitinib (Sutent) package insert]</ref><ref>[[:File:Sunitinib.pdf | Sunitinib (Sutent) package insert (locally hosted backup)]]</ref><ref>[http://sutent.com/ Sutent manufacturer's website]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>  
+
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, [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>  
  
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==Diseases for which it is used==
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==Diseases for which it is established ''(work in progress)''==
 
*[[Gastrointestinal stromal tumor]]
 
*[[Gastrointestinal stromal tumor]]
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*[[Hepatocellular carcinoma]]
 
 
*[[Pancreatic NET]]
 
*[[Pancreatic NET]]
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*[[Renal cancer]]
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*[[Renal cell carcinoma]]
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**[[Clear cell renal cell carcinoma]]
 +
**[[Non-clear cell renal cell carcinoma]]
 +
***[[Papillary renal cell carcinoma]]
 +
***[[Sarcomatoid renal cell carcinoma]]
 +
 
 +
==Diseases for which it is used==
 
*[[Small cell lung cancer]]
 
*[[Small cell lung cancer]]
 
*[[Testicular cancer]]
 
*[[Testicular cancer]]
 
*[[Thymoma]]
 
*[[Thymoma]]
 
*[[Thyroid cancer]]
 
*[[Thyroid cancer]]
 +
**[[Differentiated thyroid cancer]]
 +
**[[Medullary thyroid cancer]]
 +
 +
==Diseases for which it was used==
 +
*[[Hepatocellular carcinoma - historical|Hepatocellular carcinoma]]
  
 
==Patient drug information==
 
==Patient drug information==
 
*[http://labeling.pfizer.com/ShowLabeling.aspx?id=607 Sunitinib (Sutent) package insert]<ref name="insert"></ref>
 
*[http://labeling.pfizer.com/ShowLabeling.aspx?id=607 Sunitinib (Sutent) package insert]<ref name="insert"></ref>
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*[http://www.chemocare.com/chemotherapy/drug-info/Sunitinib.aspx Sunitinib (Sutent) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/Sunitinib.aspx Sunitinib (Sutent) patient drug information (Chemocare)]</ref>
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*[https://chemocare.com/druginfo/Sunitinib.aspx Sunitinib (Sutent) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Sunitinib.aspx Sunitinib (Sutent) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/sunitinib-patient-drug-information Sunitinib (Sutent) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/sunitinib-patient-drug-information Sunitinib (Sutent) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/sunitinib-patient-drug-information Sunitinib (Sutent) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/sunitinib-patient-drug-information Sunitinib (Sutent) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
* 1/26/2006: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf Initial FDA approval]:
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===[[Gastrointestinal stromal tumor]]===
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# "for the treatment of [[Soft tissue sarcoma | gastrointestinal stromal tumor]] after disease progression on or intolerance to [[Imatinib (Gleevec) | imatinib mesylate]]."
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*2006-01-26: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf Initial FDA approval] for the treatment of [[gastrointestinal stromal tumor]] after disease progression on or intolerance to [[Imatinib (Gleevec) | imatinib mesylate]]. ''(Based on A6181004)''
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# "for the treatment of advanced [[Renal cancer | renal cell carcinoma]]."
+
 
−
*5/20/2011: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm256499.htm FDA approved] for treatment of "Progressive, well-differentiated [[Neuroendocrine_tumors|pancreatic neuroendocrine tumors (pNET)]] in patients with unresectable locally advanced or metastatic disease."
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===[[Pancreatic NET]]===
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* 11/16/2017: FDA approved "for the adjuvant treatment of adult patients at high risk of recurrent [[Renal cancer|renal cell carcinoma]] following nephrectomy."
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*2011-05-20: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm256499.htm FDA approved] for treatment of progressive, well-differentiated [[Pancreatic NET|pancreatic neuroendocrine tumors (pNET)]] in patients with unresectable locally advanced or metastatic disease. ''(Based on A6181111)''
 +
 
 +
===[[Renal cell carcinoma]]===
 +
*2006-01-26: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf Initial accelerated approval] for the treatment of advanced [[Renal cell carcinoma | renal cell carcinoma]]. ''(Based on RTKC-0511-014 & A618-1006)''
 +
**2007-02-02: Granted regular approval for the treatment of advanced [[renal cell carcinoma]]. ''(Converted to regular approval; based on A618-1034)''
 +
*2017-11-16: Approved for the adjuvant treatment of adult patients at high risk of recurrent [[Renal cell carcinoma|renal cell carcinoma]] following nephrectomy. ''(Approval expanded to the adjuvant setting; based on S-TRAC)''
 +
 
 +
==History of changes in EMA indication==
 +
*2006-07-19: Initial authorization as Sutent. Sutent is indicated for the treatment of advanced/metastatic [[renal cell carcinoma]] (MRCC) in adults.
 +
*Uncertain date: Sutent is indicated for the treatment of unresectable and/or metastatic malignant [[gastrointestinal stromal tumor|gastrointestinal stromal tumour (GIST)]] in adults after failure of imatinib mesilate treatment due to resistance or intolerance.
 +
*Uncertain date: Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated [[Pancreatic NET|pancreatic neuroendocrine tumours]] with disease progression in adults.
  
 +
==History of changes in Health Canada indication==
 +
*2006-08-17: Initial notice of compliance with conditions
 +
*2010-04-23: Conditions were met
 +
==History of changes in PMDA indication==
 +
*2008-04-16: Initial approval for the treatment of imatinib-resistant [[Gastrointestinal stromal tumor|gastrointestinal stromal tumors]].
 +
*2008-04-16: Initial approval for the treatment of unresectable or metastatic [[Renal cell carcinoma|renal cell carcinomas]].
 +
*2012-08-10: New additional indication and a new dosage for [[Pancreatic NET|pancreatic neuroendocrine tumour]].
 
==Also known as==
 
==Also known as==
−
*'''Code names:''' SU11248, SU011248
+
*'''Code names:''' SU-11248, SU-011248
−
*'''Brand names:''' Suninat, Sutent
+
*'''Generic name:''' sunitinib malate
 +
*'''Brand names:''' Kitent, Lucisun, Suninat, Sunitix, Sutent
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
  
−
[[Category:Kinase inhibitors]]
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[[Category:CSF1R inhibitors]]
 
[[Category:FLT3 inhibitors]]
 
[[Category:FLT3 inhibitors]]
 
[[Category:KIT inhibitors]]
 
[[Category:KIT inhibitors]]
 
[[Category:PDGFR inhibitors]]
 
[[Category:PDGFR inhibitors]]
 
[[Category:RET inhibitors]]
 
[[Category:RET inhibitors]]
−
[[Category:VEGFR inhbitors]]
+
[[Category:VEGFR inhibitors]]
  
 +
[[Category:Clear cell renal cell carcinoma medications]]
 
[[Category:Gastrointestinal stromal tumor medications]]  
 
[[Category:Gastrointestinal stromal tumor medications]]  
−
[[Category:Hepatocellular carcinoma medications]]
+
[[Category:Non-clear cell renal cell carcinoma medications]]
 
[[Category:Pancreatic NET medications]]
 
[[Category:Pancreatic NET medications]]
−
[[Category:Renal cancer medications]]
+
[[Category:Papillary renal cell carcinoma medications]]
 +
[[Category:Renal_cell_carcinoma medications]]
 +
[[Category:Sarcomatoid renal cell carcinoma medications]]
 
[[Category:Small cell lung cancer medications]]
 
[[Category:Small cell lung cancer medications]]
 
[[Category:Testicular cancer medications]]
 
[[Category:Testicular cancer medications]]
 
[[Category:Thymoma medications]]
 
[[Category:Thymoma medications]]
−
[[Category:Thyroid cancer medications]]
+
[[Category:Thyroid cancer, differentiated medications]]
 +
[[Category:Thyroid cancer, medullary medications]]
 +
 
 +
[[Category:Hepatocellular carcinoma medications (historic)]]
  
−
[[Category:Drugs FDA approved in 2006]]
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[[Category:EMA approved in 2006]]
 +
[[Category:FDA approved in 2006]]
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[[Category:Health Canada approved in 2006]]
 +
[[Category:PMDA approved in 2008]]

Revision as of 01:51, 29 June 2024

General information

Class/mechanism: Tyrosine kinase inhibitor, inhibits multiple tyrosine kinases, including: vascular endothelial growth factor receptor (VEGFR1, VEGFR2 and VEGFR3), platelet-derived growth factor receptors (PDGFRα and PDGFRβ), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and RET. Inhibition of these kinases disrupts angiogenesis, tumor cell signaling, and induces apoptosis.[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 established (work in progress)

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

Gastrointestinal stromal tumor

Pancreatic NET

Renal cell carcinoma

  • 2006-01-26: Initial accelerated approval for the treatment of advanced renal cell carcinoma. (Based on RTKC-0511-014 & A618-1006)
    • 2007-02-02: Granted regular approval for the treatment of advanced renal cell carcinoma. (Converted to regular approval; based on A618-1034)
  • 2017-11-16: Approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. (Approval expanded to the adjuvant setting; based on S-TRAC)

History of changes in EMA indication

  • 2006-07-19: Initial authorization as Sutent. Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
  • Uncertain date: Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.
  • Uncertain date: Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.

History of changes in Health Canada indication

  • 2006-08-17: Initial notice of compliance with conditions
  • 2010-04-23: Conditions were met

History of changes in PMDA indication

Also known as

  • Code names: SU-11248, SU-011248
  • Generic name: sunitinib malate
  • Brand names: Kitent, Lucisun, Suninat, Sunitix, Sutent

References

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