Difference between revisions of "Sunitinib (Sutent)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Gastrointestinal stromal tumor]]=== | ===[[Gastrointestinal stromal tumor]]=== | ||
| − | *1/26/2006: [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]]. | + | *1/26/2006: [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]]=== | ||
| − | *5/20/2011: [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. ''( | + | *5/20/2011: [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]]=== | ||
| − | *1/26/2006: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf Initial accelerated | + | *1/26/2006: [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 A618-1034, RTKC-0511-014, and A618-1006)'' |
*2/2/2007: Granted regular approval for the treatment of advanced [[renal cell carcinoma]]. ''(Converted to regular approval)'' | *2/2/2007: Granted regular approval for the treatment of advanced [[renal cell carcinoma]]. ''(Converted to regular approval)'' | ||
| − | *11/16/2017: | + | *11/16/2017: 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)'' |
==Also known as== | ==Also known as== | ||
Revision as of 01:10, 11 December 2021
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 used
- Gastrointestinal stromal tumor
- Hepatocellular carcinoma
- Pancreatic NET
- Renal cell carcinoma
- Small cell lung cancer
- Testicular cancer
- Thymoma
- Thyroid cancer
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
- 1/26/2006: Initial FDA approval for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. (Based on A6181004)
Pancreatic NET
- 5/20/2011: 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
- 1/26/2006: Initial accelerated approval for the treatment of advanced renal cell carcinoma. (Based on A618-1034, RTKC-0511-014, and A618-1006)
- 2/2/2007: Granted regular approval for the treatment of advanced renal cell carcinoma. (Converted to regular approval)
- 11/16/2017: 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)
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
- Hepatocellular 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
- Differentiated thyroid cancer medications
- Medullary thyroid cancer medications
- FDA approved in 2006