VOTRIENT
Votrient (pazopanib hydrochloride) is a kinase inhibitor indicated for the treatment of adults with advanced renal cell carcinoma. It is also approved for the treatment of adults with advanced soft tissue sarcoma who have received prior chemotherapy. The drug’s efficacy has not been demonstrated for patients with gastrointestinal stromal tumors or adipocytic soft tissue sarcoma.
How VOTRIENT Works
Pazopanib is a multi-tyrosine kinase inhibitor that targets several receptors, including vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR), and fibroblast growth factor receptors (FGFR). By blocking these receptors, the drug inhibits ligand-induced autophosphorylation and prevents signaling pathways that lead to angiogenesis. This mechanism interferes with the blood supply to tumors and suppresses tumor growth.
Details
- Status
- Prescription
- First Approved
- 2009-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET
VOTRIENT Approval History
What VOTRIENT Treats
2 indicationsVOTRIENT is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Advanced renal cell carcinoma
- Advanced soft tissue sarcoma
VOTRIENT Boxed Warning
HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. ( 5.1 )...
WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. ( 5.1 )
VOTRIENT Competitors
Pro1 other drug also targets FGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (FGFR). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
VOTRIENT FDA Label Details
ProIndications & Usage
FDA Label (PDF)VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma VOTRIENT ® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma VOTRIENT is indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have...
WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.