FDA Approved Drugs » 2012
Medical Areas: Musculoskeletal | Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved April 2012
Treatment Area: soft tissue sarcoma
Votrient (pazopanib) is a vascular epidermal growth factor receptor (VEGFR) tyrosine kinase inhibitor which acts at all three isoforms: VEGFR-1, VEGFR-2 and VEGFR-3. VEGF is a chemical signal produced by cells that stimulates the growth of new blood vessels. It is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. When VEGF is overexpressed, it can contribute to disease. Solid cancers need an adequete blood supply or they will not be able to grow. Hence, cancer that can express VEGF are able to grow and metastasize.
Votrient is specifically indicated for the treatment of advanced soft tissue sarcoma in patients who have received chemotherapy.
Votrient is supplied as a tablet designed for oral administration. The recommended initial dose is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Votrient should not exceed 800 mg.
FDA ApprovalThe FDA Approval of Votrient was based on the results of a randomized, double-blind, placebo-controlled, multicenter trial named PALETTE. The study enrolled 369 subjects with soft tissue sarcoma (STS) who did not respond to previous chemotherapy treatment or who were ineligible for chemotherapy treatment. Subjects with adipocytic STS or gastrointestinal stromal tumors were excluded from the trial. Subjects were randomized 2:1 to be treated with Viotrent 800 mg per day or placebo. The primary efficacy endpoint was the rate of progression-free survival (PFS) and was assessed by independent radiological review. Secondary efficacy endpoints included overall survival (OS), overall response rate, and duration of response. The median duration of PFS among the Votrient arm was 4.6 months against 1.6 months in the placebo arm. The overall response rate in the treatment group was 4% for a duration of 9 months compared to 0% in the placebo group.
Adverse reactions associated with the use of Votrient may include, but are not limited to, the following:
For additional information regarding Votrient or soft tissue sarcoma, please visit the Votrient web page.