Story from the Wall Street JournalA Food and Drug Administration panel Monday unanimously backed a proposed GlaxoSmithKline PLC drug for treating kidney cancer, despite agency concerns about a risk of severe liver injury.
Glaxo is seeking FDA approval of the drug, pazopanib, to treat patients with advanced kidney cancer. The product was reviewed by outside medical experts who serve on the agency's oncologic drugs advisory committee.
The panel voted 10-0 in favor of whether the benefit-to-risk profile was acceptable for the treatment of patients with advanced kidney cancer. The vote amounts to a recommendation that the FDA approve pazopanib. The FDA has an Oct. 19 deadline to act on pazopanib's application.
If approved, the drug would be sold under the brand name Votrient.
An FDA staff review of pazopanib said the product was associated with a risk of severe liver injury and questioned whether the drug should be approved given that similar drugs are on the market.
Pazopanib, a tablet taken orally, works by attacking a protein involved with cancer tumor growth and blood vessels that help tumors grow.
It falls into the same class of other targeted cancer drugs approved for use in kidney cancer like Pfizer Inc.'s Sutent and Nexavar, marketed by Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. The FDA has approved five kidney-cancer treatments since December 2005, including Sutent and Nexavar.
The FDA said pazopanib appeared to work equally as well as Sutent and Nexavar.
The FDA said there were three deaths seen in clinical trials of pazopanib from liver injury that were "related to or associated with pazopanib." The agency's scientists said the "findings strongly suggest that pazopanib may be associated with a significant risk of severe idiosyncratic hepatic injury if used in a larger population."
But panel members, who included experts in liver injury, said it wasn't clear if the three deaths were from drug-induced liver injury.
During the panel meeting, representatives from GlaxoSmithKline noted that the other cancer drugs have different side effects, making some drugs better for some patients than others, a view backed by the FDA panel.
Glaxo is seeking FDA approval of the drug, pazopanib, to treat patients with advanced kidney cancer. The product was reviewed by outside medical experts who serve on the agency's oncologic drugs advisory committee.
The panel voted 10-0 in favor of whether the benefit-to-risk profile was acceptable for the treatment of patients with advanced kidney cancer. The vote amounts to a recommendation that the FDA approve pazopanib. The FDA has an Oct. 19 deadline to act on pazopanib's application.
If approved, the drug would be sold under the brand name Votrient.
An FDA staff review of pazopanib said the product was associated with a risk of severe liver injury and questioned whether the drug should be approved given that similar drugs are on the market.
Pazopanib, a tablet taken orally, works by attacking a protein involved with cancer tumor growth and blood vessels that help tumors grow.
It falls into the same class of other targeted cancer drugs approved for use in kidney cancer like Pfizer Inc.'s Sutent and Nexavar, marketed by Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. The FDA has approved five kidney-cancer treatments since December 2005, including Sutent and Nexavar.
The FDA said pazopanib appeared to work equally as well as Sutent and Nexavar.
The FDA said there were three deaths seen in clinical trials of pazopanib from liver injury that were "related to or associated with pazopanib." The agency's scientists said the "findings strongly suggest that pazopanib may be associated with a significant risk of severe idiosyncratic hepatic injury if used in a larger population."
But panel members, who included experts in liver injury, said it wasn't clear if the three deaths were from drug-induced liver injury.
During the panel meeting, representatives from GlaxoSmithKline noted that the other cancer drugs have different side effects, making some drugs better for some patients than others, a view backed by the FDA panel.
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