Experimental Kidney Cancer Drug Votrient Linked to Liver Injuries

Votrient, the experimental kidney cancer drug being developed by GlaxoSmithKline PLC, may be too dangerous due to risks of liver damage to be approved, Food and Drug Administration staffers say.

The drug, known chemically as pazopanib, is designed to treat advanced forms of renal cell carcinoma. If approved, Votrient would be the sixth drug approved in the United States to treat the disease, according to a Reuters news report. Sutent (Pfizer), Avastin (Genentech), Torisel (Wyeth), Afinitor (Novartis AG), and Nexavar (Onyx Pharmaceuticals Inc and Bayer AG) are the other renal cell cancer drugs already on the U.S. market.

Votrient targets a vascular endothelial growth factor (VEGF) receptor to limit new blood vessels that can feed cancerous tumors.

Votrient Seeking FDA Approvals

However, Votrient is already hitting roadblocks on the path to FDA approvals.

Glaxo said its own internal data showed that Votrient resulted in a five-month improvement in median progression-free survival, but FDA staffers reviewing the company’s application detected no “statistically significant improvement” in overall survival among patients given the drug.

“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 in a memo released today.

FDA Panel to Meet on Votrient

An FDA advisory panel is set to meet next week to decide whether to recommend approval for Votrient. The FDA is not obligated to follow the recommendation of its advisory panels, but most of the time, it does. Glaxo has said it expects the FDA to make its approval decision by October 19, Reuters said.

Glaxo officials say Votrient is effective and “represents a valuable option for the treatment” of renal cell cancers. But FDA staffers say they have concerns about the drug, particularly an apparent link to elevated levels of a liver enzyme, ALT, compared to placebo.

There were three liver-related deaths linked to use of Votrient, which may “strongly suggest” that the drug can significantly increase the risks of severe liver injury if approved, FDA staffers said.

Votrient and other similar cancer drugs called VEGF inhibitors are known to cause blood clots, high blood pressure, and tears (perforations) of the intestines and stomach, the FDA said.

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