Difference between revisions of "Sunitinib (Sutent)"

Revision as of 14:59, 26 November 2018

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

Patient drug information

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.

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. (New disease entity)

Renal cell carcinoma

1/26/2006: Initial accelerated FDA approval for the treatment of advanced renal cell carcinoma.
2/2/2007: Granted regular approval for the treatment of advanced renal cell carcinoma. (Converted to regular approval)
11/16/2017: FDA approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. (Approval expanded to the adjuvant setting)

Also known as

Code names: SU11248, SU011248
Brand names: Suninat, Sutent

References

[insert-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)

[1]

[2]

[3]

[4]

[5]

@@ Line 22: / Line 22: @@
 ==History of changes in FDA indication==
-* 1/26/2006: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf Initial FDA approval]:
+===[[Gastrointestinal stromal tumor]]===
-# "for the treatment of [[Soft tissue sarcoma | 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]].
-# "for the treatment of advanced [[Renal cell carcinoma | 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."
+===[[Pancreatic NET]]===
-* 11/16/2017: FDA approved "for the adjuvant treatment of adult patients at high risk of recurrent [[Renal cell carcinoma|renal cell carcinoma]] following nephrectomy."
+*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. ''(New disease entity)''
+===[[Renal cell carcinoma]]===
+*1/26/2006: [http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf Initial accelerated FDA approval] for the treatment of advanced [[Renal cell carcinoma | renal cell carcinoma]].
+*2/2/2007: Granted regular approval for the treatment of advanced renal cell carcinoma. ''(Converted to regular approval)''
+*11/16/2017: FDA 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)''
 ==Also known as==