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.^[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

Hepatocellular carcinoma

Patient drug information

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

[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)

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