An experimental kidney cancer drug called pazopanib may cause liver damage that outweighs the its ability to slow the cancer, according to U.S. Food and Drug Administration documents posted online.
GlaxoSmithKline is seeking FDA approval of pazopanib for treatment of advanced kidney cancer. However, the FDA documents say there have been three liver damage-related deaths among patients taking the pill, and other patients have shown elevated levels of enzymes that often predict liver damage, the Associated Press reported.
These cases "strongly suggest that pazopanib may be associated with a significant risk of severe idiosyncratic hepatic injury if used in a large patient population," FDA reviewers said in the documents.
It was also noted that the drug causes side effects common to other cancer drugs, including blood clots, internal bleeding and hypertension, the AP reported.
An FDA panel of experts will decide Monday whether to recommend approval of the drug. The agency isn't required to follow the advice of its expert panels, but usually does.