(ChemotherapyAdvisor) – The US Food and Drug Administration has approved the oral kinase inhibitor Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy.

Paolo Paoletti, MD, President of GlaxoSmithKline (GSK) Oncology, noted Votrient “represents one of the few new medical options to be provided to patients with advanced soft tissue sarcoma over the last 30 years.”

Approval, which occurred on April 26, is based on a pivotal, randomized, double blind, placebo controlled, multicenter Phase 3 study known as PALETTE (PAzopanib ExpLorEd in sofT Tissue sarcoma), which was conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC). A total of 369 patients with more than 20 subtypes of sarcoma who had received prior chemotherapy were randomly assigned to Votrient or placebo. Those with GIST or adipocytic sarcomas were excluded from the trial.

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Progression-free survival, the primary end point, was 4.6 months for patients in the Votrient group vs. 1.6 months for placebo. The most common adverse events in the Votrient group were fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, hair color changes, vomiting, tumor pain, dysgeusia, headache, musculoskeletal pain, myalgia, gastrointestinal pain, and dyspnea.

Votrient, which was first approved in October 2009 for the treatment of advanced renal cell carcinoma, was granted an orphan drug status for the soft tissue sarcoma indication. Soft tissue sarcoma occurs in approximately 11,000 patients annually in the United States.

The US label contains the following limitations: “The efficacy of Votrient for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.”

Votrient prescribing information includes a warning that “severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.”

Votrient is marketed by GlaxoSmithKline, Research Triangle Park, NC.

FDA Press Release

GSK Press Release