Difference between revisions of "Pazopanib (Votrient)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Tyrosine kinase inhibitor of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptors FGFR-1 and FGFR-3, cytokine receptor (Kit), interleukin-2 receptor inducible T-cell kinase (Itk), leukocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). Interferes tumor angiogenesis, growth, and cancer progression.<ref name="insert">[ | + | Class/mechanism: Tyrosine kinase inhibitor of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptors FGFR-1 and FGFR-3, cytokine receptor (Kit), interleukin-2 receptor inducible T-cell kinase (Itk), leukocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). Interferes tumor angiogenesis, growth, and cancer progression.<ref name="insert">[https://www.novartis.us/sites/www.novartis.us/files/votrient.pdf Pazopanib (Votrient) package insert]</ref><ref>[[:File:Pazopanib.pdf | Pazopanib (Votrient) package insert (locally hosted backup)]]</ref><ref>[https://votrient.com/ Votrient manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>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 | + | 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, [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
| + | |||
| + | ==Diseases for which it is established ''(work in progress)''== | ||
| + | *[[Ovarian cancer]] | ||
| + | *[[Renal cell carcinoma]] | ||
| + | **[[Clear cell renal cell carcinoma]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | *[[ | + | *[[Angiosarcoma]] |
| − | *[[ | + | *[[Soft tissue sarcoma]] |
| − | *[[Gastrointestinal stromal tumor]] | + | **[[Desmoid tumors]] |
| − | *[[ | + | **[[Gastrointestinal stromal tumor]] |
| + | *Thyroid cancer | ||
| + | **[[Differentiated thyroid cancer]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://www.novartis.us/sites/www.novartis.us/files/votrient.pdf Pazopanib (Votrient) package insert]<ref name="insert"></ref> |
| − | *[ | + | *[https://chemocare.com/druginfo/Pazopanib.aspx Pazopanib (Votrient) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Pazopanib.aspx Pazopanib (Votrient) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/pazopanib-patient-drug-information Pazopanib (Votrient) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/pazopanib-patient-drug-information Pazopanib (Votrient) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/pazopanib-patient-drug-information Pazopanib (Votrient) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/pazopanib-patient-drug-information Pazopanib (Votrient) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * 10 | + | * 2009-10-19: Initial FDA approval for the treatment of patients with advanced [[Renal cell carcinoma | renal cell carcinoma]]. ''(Based on VEG105192)'' |
| − | * | + | * 2012-04-26: New indication for patients with advanced [[Soft tissue sarcoma | soft tissue sarcoma]] who have received prior chemotherapy. The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. ''(Based on PALETTE)'' |
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2010-06-14: Initial marketing authorization as Votrient. Votrient is indicated for the first line treatment of advanced [[Renal cell carcinoma|Renal Cell Carcinoma (RCC)]] and for patients who have received prior cytokine therapy for advanced disease. ''(Based on VEG105192)'' | ||
| + | *2012-08-03: Extension of indication for the treatment of patients with advanced [[Soft tissue sarcoma|Soft Tissue Sarcoma (STS)]]. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2010-05-27: Initial notice of compliance for the treatment of patients with metastatic [[Clear cell renal cell carcinoma|renal cell (clear cell) carcinoma]] (mRCC) who have received no prior systemic therapies. | ||
| + | *2010-05-27: Initial notice of compliance for the treatment of patients with metastatic [[Clear cell renal cell carcinoma|renal cell (clear cell) carcinoma]] (mRCC) who have received prior treatment with cytokines for metastatic disease. | ||
| + | *2012-07-12: New indication for the treatment of adult patients with selective subtypes of advanced [[Soft tissue sarcoma|Soft Tissue Sarcoma (STS)]] who have received prior chemotherapy for metastatic disease. Patients were required to have disease progression on or after, or be intolerant to, an anthracyline-based regimen in the pivotal phase III study in STS. | ||
| + | *2012-07-12: New indication for the treatment of adult patients with selective subtypes of advanced [[Soft tissue sarcoma|Soft Tissue Sarcoma (STS)]] who have progressed within 12 months after (neo)adjuvant therapy. Patients were required to have disease progression on or after, or be intolerant to, an anthracyline-based regimen in the pivotal phase III study in STS. | ||
| + | *2013-07-19: Revisions to the indication for renal cell carcinoma to: Indicated for the first line treatment of patients with metastatic [[Clear cell renal cell carcinoma|renal cell (clear cell) carcinoma]] (mRCC). | ||
| + | *2013-07-19: Revisions to the indication for renal cell carcinoma to: Indicated for the treatment of metastatic [[Clear cell renal cell carcinoma|renal cell (clear cell) carcinoma]] (mRCC) for patients who have received prior treatment with cytokines for metastatic disease. | ||
| + | |||
| + | ==History of changes in PMDA indication== | ||
| + | *2012-09-28: Initial approval for the treatment of [[soft tissue sarcoma]]. | ||
| + | *2014-03-17: New additional indication for the treatment of unresectable or metastatic [[renal cell carcinoma]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' GW-786034B |
| − | *'''Brand name:''' Votrient | + | *'''Generic name:''' pazopanib hydrochloride |
| + | *'''Brand name:''' Pazopater, Votrient | ||
==References== | ==References== | ||
| Line 31: | Line 54: | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | + | ||
[[Category:FGFR inhibitors]] | [[Category:FGFR inhibitors]] | ||
[[Category:KIT inhibitors]] | [[Category:KIT inhibitors]] | ||
| Line 38: | Line 61: | ||
[[Category:VEGFR inhibitors]] | [[Category:VEGFR inhibitors]] | ||
| + | [[Category:Angiosarcoma medications]] | ||
| + | [[Category:Clear cell renal cell carcinoma medications]] | ||
[[Category:Ovarian cancer medications]] | [[Category:Ovarian cancer medications]] | ||
| − | [[Category: | + | [[Category:Renal cell carcinoma medications]] |
| + | [[Category:Soft tissue sarcoma medications]] | ||
| + | [[Category:Desmoid tumor medications]] | ||
[[Category:Gastrointestinal stromal tumor medications]] | [[Category:Gastrointestinal stromal tumor medications]] | ||
| − | [[Category:Thyroid cancer medications]] | + | [[Category:Thyroid cancer, differentiated medications]] |
| − | [[Category: | + | [[Category:EMA approved in 2010]] |
| + | [[Category:FDA approved in 2009]] | ||
| + | [[Category:Health Canada approved in 2010]] | ||
| + | [[Category:PMDA approved in 2012]] | ||
Latest revision as of 12:07, 29 June 2024
General information
Class/mechanism: Tyrosine kinase inhibitor of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptors FGFR-1 and FGFR-3, cytokine receptor (Kit), interleukin-2 receptor inducible T-cell kinase (Itk), leukocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). Interferes tumor angiogenesis, growth, and cancer progression.[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
- Angiosarcoma
- Soft tissue sarcoma
- Thyroid cancer
Patient drug information
- Pazopanib (Votrient) package insert[1]
- Pazopanib (Votrient) patient drug information (Chemocare)[4]
- Pazopanib (Votrient) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2009-10-19: Initial FDA approval for the treatment of patients with advanced renal cell carcinoma. (Based on VEG105192)
- 2012-04-26: New indication for patients with advanced soft tissue sarcoma who have received prior chemotherapy. The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. (Based on PALETTE)
History of changes in EMA indication
- 2010-06-14: Initial marketing authorization as Votrient. Votrient is indicated for the first line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. (Based on VEG105192)
- 2012-08-03: Extension of indication for the treatment of patients with advanced Soft Tissue Sarcoma (STS).
History of changes in Health Canada indication
- 2010-05-27: Initial notice of compliance for the treatment of patients with metastatic renal cell (clear cell) carcinoma (mRCC) who have received no prior systemic therapies.
- 2010-05-27: Initial notice of compliance for the treatment of patients with metastatic renal cell (clear cell) carcinoma (mRCC) who have received prior treatment with cytokines for metastatic disease.
- 2012-07-12: New indication for the treatment of adult patients with selective subtypes of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease. Patients were required to have disease progression on or after, or be intolerant to, an anthracyline-based regimen in the pivotal phase III study in STS.
- 2012-07-12: New indication for the treatment of adult patients with selective subtypes of advanced Soft Tissue Sarcoma (STS) who have progressed within 12 months after (neo)adjuvant therapy. Patients were required to have disease progression on or after, or be intolerant to, an anthracyline-based regimen in the pivotal phase III study in STS.
- 2013-07-19: Revisions to the indication for renal cell carcinoma to: Indicated for the first line treatment of patients with metastatic renal cell (clear cell) carcinoma (mRCC).
- 2013-07-19: Revisions to the indication for renal cell carcinoma to: Indicated for the treatment of metastatic renal cell (clear cell) carcinoma (mRCC) for patients who have received prior treatment with cytokines for metastatic disease.
History of changes in PMDA indication
- 2012-09-28: Initial approval for the treatment of soft tissue sarcoma.
- 2014-03-17: New additional indication for the treatment of unresectable or metastatic renal cell carcinoma.
Also known as
- Code name: GW-786034B
- Generic name: pazopanib hydrochloride
- Brand name: Pazopater, Votrient
References
Categories:
- Drugs
- Oral medications
- FGFR inhibitors
- KIT inhibitors
- PDGFR inhibitors
- SRC inhibitors
- VEGFR inhibitors
- Angiosarcoma medications
- Clear cell renal cell carcinoma medications
- Ovarian cancer medications
- Renal cell carcinoma medications
- Soft tissue sarcoma medications
- Desmoid tumor medications
- Gastrointestinal stromal tumor medications
- Thyroid cancer, differentiated medications
- EMA approved in 2010
- FDA approved in 2009
- Health Canada approved in 2010
- PMDA approved in 2012