GlaxoSmithKline announced that the FDA has approved Votrient (pazopanib) 200mg tablets for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. 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.
The approval for Votrient is based on the results a randomized, double-blind, placebo-controlled, multi-center Phase III study called PALETTE (PAzopanib ExpLorEd in sofT Tissue sarcoma). The primary endpoint of progression-free survival per independent review was significantly prolonged with pazopanib (median: 20 vs. 7 weeks; HR=0.31, 95% CI 0.24-0.4; P<0.0001).
Votrient, a kinase inhibitor, is already indicated for the treatment of advanced renal cell carcinoma in adults.
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