GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) has approved Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy. The U.S. 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.
“GSK Oncology feels fortunate to have collaborated with the European Organization for Research and Treatment of Cancer in completing a rigorous Phase 3 trial in such a rare cancer,” said Paolo Paoletti, M.D., President, GSK Oncology.
The approval for VOTRIENT is based on the results of the pivotal, randomized, double-blind, placebo-controlled, multicenter Phase 3 study called PALETTE (PAzopanib ExpLorEd in sofT Tissue sarcoma).
Date: April 26, 2012
Source: GlaxoSmithKline plc
Filed Under: Drug Discovery
