Sunitinib (Sutent)

==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.Sunitinib (Sutent) package insert Sunitinib (Sutent) package insert (locally hosted backup)Sutent manufacturer's website
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, or the prescribing information. 
==Diseases for which it is established (work in progress)==
*Gastrointestinal stromal tumor
*Pancreatic NET
*Renal cell carcinoma
**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
*Testicular cancer
*Thymoma
*Thyroid cancer
**Differentiated thyroid cancer
**Medullary thyroid cancer
==Diseases for which it was used==
*Hepatocellular carcinoma
==Patient drug information==
*Sunitinib (Sutent) package insert
*Sunitinib (Sutent) patient drug information (Chemocare)Sunitinib (Sutent) patient drug information (Chemocare)
*Sunitinib (Sutent) patient drug information (UpToDate)Sunitinib (Sutent) patient drug information (UpToDate)
==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: Adsunib, Inayataj, Kitent, Lucisun, Nitnib, Rcnet, Sunitcap, Sunitix, Sunicine, Suninat, Sunisam, Sunixar, Sutent, Sutib, Sutekast, Sukinsa, Sutykine, Sugistran, Svitinib, Tunib
==References==
Category:Drugs
Category:Oral medications
Category:CSF1R inhibitors
Category:FLT3 inhibitors
Category:KIT inhibitors
Category:PDGFR inhibitors
Category:RET inhibitors
Category:VEGFR inhibitors
Category:Clear cell renal cell carcinoma medications
Category:Gastrointestinal stromal tumor medications 
Category:Non-clear cell renal cell carcinoma medications
Category:Pancreatic NET 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:Testicular cancer medications
Category:Thymoma medications
Category:Thyroid cancer, differentiated medications
Category:Thyroid cancer, medullary medications
Category:Hepatocellular carcinoma medications (historic)
Category:EMA approved in 2006
Category:FDA approved in 2006
Category:Health Canada approved in 2006
Category:PMDA approved in 2008