FDA advisory committee votes in favor of GSK's Votrient

Drug maker seeks approval for drug in soft-tissue carcinoma

PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

"Treatment options for patients with advanced soft-tissue sarcoma are limited," GSK Oncology SVP Rafael Amado said. "We are therefore pleased that the committee took a favorable view of the clinical data for Votrient."

The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug but usually follows them.



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