GlaxoSmithKline plc (GSK, GSK.L) said Thursday that the U.S. Food and Drug Administration has approved Votrient for the treatment of patients with advanced soft tissue sarcoma, or STS, who received prior chemotherapy.
The company said the U.S. label contains the limitation that the efficacy of Votrient for the treatment of patients with adipocytic STS or astrointestinal stromal tumors has not been demonstrated.
"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," Paoletti said.
The company said the approval for Votrient (pazopanib) is based on the results of the pivotal, randomized, double-blind, placebo controlled, Phase III study called PALETTE (PAzopanib ExpLorEd in sofT Tissue sarcoma).
STS 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 U.S. was 10,980 patients, according to the American Cancer Society. Fewer patients have advanced STS for which they previously received chemotherapy.
by RTT Staff Writer
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