FDA panel backs Glaxo's new kidney cancer drug

An expert panel gathered by the FDA has endorsed GlaxoSmithKline's new kidney cancer therapy, pazopanib. The group voted unanimously that the drug, which Glaxo plans to market as a treatment for advanced cases, had an acceptable benefit-to-risk ratio. The oral therapy is designed to stunt the growth of tumors by attacking a protein needed by the blood vessels that feed tumors.

The agency now faces an action date of October 19 as it reviews a possible addition to a drug class that includes Sutent and Nexavar. Agency staffers have said that Glaxo's new drug appears to work as well as the others. The therapy, which will be sold as Votrient, is associated with a different set of side effects, which would make it appealing to doctors seeking new cancer drugs to offer patients. And panel members weren't as concerned as the agency's scientists by the deaths of three patients involved in clinical trials. While federal scientists said that the deaths resulted in liver injuries linked to the drug, the experts weren't convinced. 

"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," said Rafael Amado, MD, Vice President, GlaxoSmithKline Oncology R&D Unit. "We look forward to working with the FDA towards the approval of pazopanib."

- see GSK's statement
- check out the report from the Wall Street Journal
- here's the Reuters story