FDA approves Votrient (GSK) to treat Soft Tissue Sarcoma

The FDA on 26 April 2012 approved Votrient (pazopanib)from Glaxo Smith Kline to treat patients with advanced Soft Tissue Sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues. A rare cancer with many subtypes, Soft Tissue Sarcoma occurs in about 10,000 cases annually in the United States. More than 20 subtypes of sarcoma were included in the clinical trial leading to approval of Votrient. The drug is not approved for patients with adipocytic soft tissue sarcoma and gastrointestinal stromal tumors. The safety and effectiveness of Votrient was evaluated in a single clinical study in 369 patients with advanced Soft Tissue Sarcoma who had received prior chemotherapy. Patients were randomly selected to receive Votrient or a placebo. The study was designed to measure the length of time a patient lived without the cancer progressing (progression-free survival). The disease did not progress for a median of 4.6 months for patients receiving Votrient, compared with 1.6 months for those receiving the placebo.