Reuters (KC) 07-Oct-09
From Kidney Cancer Resource
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UPDATE 2-Glaxo kidney cancer drug wins U.S. panel support
- Agency will consider vote, make final decision
- Drug would be sixth one on U.S. market (Adds background on drug, comments from panel)
GAITHERSBURG, Md., Oct 5 (Reuters) -A U.S. Food and Drug Administration advisory panel gave GlaxoSmithKline's (GSK.L) (GSK.N) experimental kidney cancer drug Votrient its full support on Monday, saying the drug appeared effective and no more risky than other similar medications.
The drugmaker is seeking to market Votrient, also known by its chemical name pazopanib, to treat advanced renal cell carcinoma. If approved, it would be the sixth drug on the U.S. market to treat the disease.
FDA's panel of outside experts agreed with company officials that the drug would offer doctors another choice in treating patients with side effects that are somewhat different than those of its rivals.
The FDA will weigh the panel's vote before deciding whether to approve the drug.
Other approved renal cell cancer drugs include Pfizer's (PFE.N) Sutent, Roche (ROG.VX) unit Genentech's Avastin, Wyeth's (WYE.N) Torisel, Novartis AG's (NOVN.VX) Afinitor, and Onyx Pharmaceuticals Inc (ONXX.O) and Bayer AG's (BAYGn.DE) Nexavar.
Some of them, like Votrient, target the vascular endothelial growth factor (VEGF) receptor to try to limit new blood vessels that can feed tumors.
"They all have their pluses and minuses," said panel member Dr. Michael Kelly, an associate medical professor at Yale University. "This drug here definitely does have clinical activity, and the spectrum of side effects ... are different but may not be any more severe than the ones out there now."
Company data showed Votrient caused liver-related problems and possibly death, FDA staff told the panel.
Other side effects included diarrhea and heart problems, which Glaxo said are also seen with other VEGF drugs. Unlike rivals, Votrient led to fewer reports of skin problems and fatigue, the drugmaker said.
Panel members also urged Glaxo to complete its current study comparing its drug to Pfizer's Sutent, which has become the standard drug used in the United States. They also said the company needs to closely monitor side effects even if it wins approval.
Glaxo, in a statement, said it would continue to work with the FDA. After the vote, shares of the British drugmaker closed 0.4 percent higher at $38.86 on the New York Stock Exchange. (Reporting by Susan Heavey; editing by Carol Bishopric and Gunna Dickson)
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