SUTENT
SUTENT (sunitinib malate) is a kinase inhibitor indicated for the treatment of several types of solid tumors in adult patients. It is used to treat advanced renal cell carcinoma (RCC) and serves as an adjuvant therapy for patients at high risk of RCC recurrence following a nephrectomy. The medication is also approved for patients with gastrointestinal stromal tumors (GIST) who have experienced disease progression on or intolerance to imatinib, as well as those with progressive, unresectable, or metastatic pancreatic neuroendocrine tumors (pNET).
How SUTENT Works
Sunitinib functions as a small molecule inhibitor of multiple receptor tyrosine kinases (RTKs) that contribute to tumor growth, pathologic angiogenesis, and metastatic progression. The drug targets several specific receptors, including vascular endothelial growth factor receptors (VEGFR) and platelet-derived growth factor receptors (PDGFR), which are essential for tumor blood supply and cell proliferation. By inhibiting the activity and phosphorylation of these RTKs, sunitinib reduces the growth of tumor cells and prevents the formation of new blood vessels within the tumor environment.
Details
- Status
- Prescription
- First Approved
- 2006-01-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SUTENT Approval History
What SUTENT Treats
4 indicationsSUTENT is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastrointestinal stromal tumor (GIST)
- Advanced renal cell carcinoma (RCC)
- Adjuvant treatment of renal cell carcinoma (RCC) at high risk of recurrence following nephrectomy
- Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET)
SUTENT Boxed Warning
HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ]....
WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ].
SUTENT Competitors
Pro10 other drugs also target RET. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (RET). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUTENT FDA Label Details
ProIndications & Usage
FDA Label (PDF)SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. • treatment of adult patients with advanced renal cell carcinoma (RCC). • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. • treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. 1.1 Gastrointestinal Stromal Tumor SUTENT is indicated for the treatment of adult patient...
WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepat...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.