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Liver Risk Seen in GlaxoSmithKline’s Proposed Kidney-Cancer Drug Votrient pazopanib

By Bettina Padurano for CEOWORLD Magazine Updated:October 1, 2009

GlaxoSmithKline Plc’s (GSK.L) (GSK.N) experimental treatment for advanced kidney cancer causes side effects, according to the U.S. Food and Drug Administration. In online documents, FDA reviewers say the drug slows the progression of cancer, though patients did not live significantly longer.

The FDA also noted three deaths related to liver damage with the drug, in addition to side effects like hypertension, internal bleeding and blood clots.

Votrient, also known by its chemical name pazopanib, aims to treat advanced renal cell carcinoma. But while the company’s data showed a five-month improvement in median progression-free survival, the FDA reviewers saw no “statistically significant improvement” in overall survival.

“FDA is concerned about the benefit-to-risk ratio of pazopanib in the intended population of patients. This is particularly true in a setting in which there are other effective products approved for the treatment of advanced renal cell cancer,” the staffers wrote.

If approved, it would be the sixth medication on the U.S. market to treat the disease.

Other 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, Reuters reported.

Along with liver risks, FDA scientists also noted side effects common to other cancer drugs, including hypertension, internal bleeding and blood clots.

The FDA will ask a panel of experts Monday whether pazopanib should be approved, though the negative tone of the agency’s review suggests Glaxo faces an uphill battle. The FDA is not required to follow the group’s advice, though it usually does.

Glaxo will make the case Monday that its drug could still be a useful option for patients, despite safety concerns and a variety of drugs already on the market.

“GSK will present an overview of a complete package of clinical data that demonstrates how this medicine may benefit patients with this serious disease,” the company said in a statement.

When Glaxo began developing its drug there were few treatment options for advanced kidney cancer, which killed about 13,000 people in the U.S. last year, according to the American Cancer Society.

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