Pazopanib (Votrient)

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.
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.

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

• Angiosarcoma
• Soft tissue sarcoma
  • Desmoid tumors
  • Gastrointestinal stromal tumor
• Thyroid cancer
  • Differentiated thyroid cancer

Patient drug information

• Pazopanib (Votrient) package insert
• Pazopanib (Votrient) patient drug information (Chemocare)
• Pazopanib (Votrient) patient drug information (UpToDate)

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