FDA unanimously recommends GSK's kidney cancer treatment

PHILADELPHIA A Food and Drug Administration advisory committee has recommended approval for a new kidney cancer drug.

GlaxoSmithKline announced that the FDA’s Oncologic Drugs Advisory Committee had voted unanimously to recommend approval for Votrient (pazopanib), an investigational pill-based treatment for renal cell carcinoma.

“Kidney cancer is a very serious disease, therefore the committee’s recommendation in support of pazopanib is an important step towards bringing a new, oral treatment option to advanced renal cell cancer patients,” GSK VP oncology research and development Rafael Amado said in a statement. “We look forward to working with the FDA towards the approval of pazopanib.”

The committee based its decision based on a phase 3 trial presented at the American Society of Clinical Oncology’s annual meeting this year. FDA advisory committees’ recommendations don’t guarantee full FDA approval, but are taken into account when the agency decides whether to approve a drug.