Difference between revisions of "Sunitinib (Sutent)"
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<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 | + | 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> |
==Diseases for which it is established ''(work in progress)''== | ==Diseases for which it is established ''(work in progress)''== | ||
| Line 10: | Line 10: | ||
*[[Pancreatic NET]] | *[[Pancreatic NET]] | ||
*[[Renal cell carcinoma]] | *[[Renal cell carcinoma]] | ||
| + | **[[Clear cell renal cell carcinoma]] | ||
**[[Non-clear cell renal cell carcinoma]] | **[[Non-clear cell renal cell carcinoma]] | ||
***[[Papillary renal cell carcinoma]] | ***[[Papillary renal cell carcinoma]] | ||
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==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> | ||
| − | *[https://chemocare.com/ | + | *[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> | ||
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *2006-07-19: Initial authorization | + | *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== | ==History of changes in Health Canada indication== | ||
*2006-08-17: Initial notice of compliance with conditions | *2006-08-17: Initial notice of compliance with conditions | ||
| Line 52: | Line 56: | ||
*2012-08-10: New additional indication and a new dosage for [[Pancreatic NET|pancreatic neuroendocrine tumour]]. | *2012-08-10: New additional indication and a new dosage for [[Pancreatic NET|pancreatic neuroendocrine tumour]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' | + | *'''Code names:''' SU-11248, SU-011248 |
*'''Generic name:''' sunitinib malate | *'''Generic name:''' sunitinib malate | ||
*'''Brand names:''' Kitent, Lucisun, Suninat, Sunitix, Sutent | *'''Brand names:''' Kitent, Lucisun, Suninat, Sunitix, Sutent | ||
| Line 69: | Line 73: | ||
[[Category:VEGFR inhibitors]] | [[Category:VEGFR inhibitors]] | ||
| + | [[Category:Clear cell renal cell carcinoma medications]] | ||
[[Category:Gastrointestinal stromal tumor medications]] | [[Category:Gastrointestinal stromal tumor medications]] | ||
[[Category:Non-clear cell renal cell carcinoma medications]] | [[Category:Non-clear cell renal cell carcinoma medications]] | ||
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
- Sunitinib (Sutent) package insert[1]
- Sunitinib (Sutent) patient drug information (Chemocare)[4]
- Sunitinib (Sutent) patient drug information (UpToDate)[5]
History of changes in FDA indication
Gastrointestinal stromal tumor
- 2006-01-26: Initial FDA approval for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. (Based on A6181004)
Pancreatic NET
- 2011-05-20: FDA approved for treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. (Based on A6181111)
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
- 2008-04-16: Initial approval for the treatment of imatinib-resistant gastrointestinal stromal tumors.
- 2008-04-16: Initial approval for the treatment of unresectable or metastatic renal cell carcinomas.
- 2012-08-10: New additional indication and a new dosage for pancreatic neuroendocrine tumour.
Also known as
- Code names: SU-11248, SU-011248
- Generic name: sunitinib malate
- Brand names: Kitent, Lucisun, Suninat, Sunitix, Sutent
References
Categories:
- Drugs
- Oral medications
- CSF1R inhibitors
- FLT3 inhibitors
- KIT inhibitors
- PDGFR inhibitors
- RET inhibitors
- VEGFR inhibitors
- Clear cell renal cell carcinoma medications
- Gastrointestinal stromal tumor medications
- Non-clear cell renal cell carcinoma medications
- Pancreatic NET medications
- Papillary renal cell carcinoma medications
- Renal cell carcinoma medications
- Sarcomatoid renal cell carcinoma medications
- Small cell lung cancer medications
- Testicular cancer medications
- Thymoma medications
- Thyroid cancer, differentiated medications
- Thyroid cancer, medullary medications
- Hepatocellular carcinoma medications (historic)
- EMA approved in 2006
- FDA approved in 2006
- Health Canada approved in 2006
- PMDA approved in 2008