The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy.
The US label contains the limitations of: The efficacy of Votrient for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
Votrient (pazopanib) 200 mg tablets is now approved for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy. Limitation of Use: The efficacy of Votrient for the treatment of patients with adipocytic STS or gastrointestinal stromal tumours has not been demonstrated. Votrient, an oral medication, was approved for the treatment of advanced renal cell carcinoma in adults in 2009 in the United States.
“It is such a great moment to bring forth this treatment option for patients, as it represents one of the few new medical options to be provided to patients with advanced soft tissue sarcoma over the last thirty years,” said Paolo Paoletti, M.D., president, GSK Oncology. “GSK Oncology feels fortunate to have collaborated with the European Organization for Research and Treatment of Cancer (EORTC) in completing a rigorous phase III trial in such a rare cancer.”
The approval for Votrient is based on the results of the pivotal, randomized, double-blind, placebo controlled, multi-centre phase III study called PALETTE (PAzopanib ExpLorEd in sofT Tissue sarcoma).
Soft tissue sarcomas constitute a group of rare cancers arising from mesenchymal cells. These cells normally give rise to soft tissues including fat, muscle, nerve, blood vessels and other connective tissues. The incidence of STS in 2011 in the US was 10,980 patients, according to the American Cancer Society. Fewer patients have advanced STS for which they previously received chemotherapy. The composition of the PALETTE trial population was further limited because patients with GIST or adipocytic sarcomas were not included.