Difference between revisions of "Sunitinib (Sutent)"
Jump to navigation
Jump to search
Warner-admin (talk | contribs) m (Text replacement - "Category:Medullary thyroid cancer medications" to "Category:Thyroid cancer, medullary medications") |
m |
||
| Line 32: | Line 32: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Gastrointestinal stromal tumor]]=== | ===[[Gastrointestinal stromal tumor]]=== | ||
| − | * | + | *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)'' |
===[[Pancreatic NET]]=== | ===[[Pancreatic NET]]=== | ||
| − | * | + | *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]]=== | ===[[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)'' |
| − | *11 | + | *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 | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2006-08-17: Initial notice of compliance with conditions | ||
| + | *2010-04-23: Conditions were met | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' SU11248, SU011248 | *'''Code names:''' SU11248, SU011248 | ||
| Line 74: | Line 78: | ||
[[Category:Hepatocellular carcinoma medications (historic)]] | [[Category:Hepatocellular carcinoma medications (historic)]] | ||
| + | [[Category:EMA approved in 2006]] | ||
[[Category:FDA approved in 2006]] | [[Category:FDA approved in 2006]] | ||
| + | [[Category:Health Canada approved in 2006]] | ||
Revision as of 11:37, 31 March 2023
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
History of changes in Health Canada indication
- 2006-08-17: Initial notice of compliance with conditions
- 2010-04-23: Conditions were met
Also known as
- Code names: SU11248, SU011248
- 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
- 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