March 30, 2009

Afinitor Approved for Advanced Kidney Cancer

MONDAY, March 30 (HealthDay News) -- The Novartis drug Afinitor (everolimus) has been approved to treat advanced kidney cancer in people whose cancer has progressed despite treatment with other therapies, the U.S. Food and Drug Administration said Monday.

The most common form of kidney cancer, renal cancer, is resistant to radiation therapies and chemotherapy. For most people diagnosed with renal cancer, the most common initial treatment is surgical removal of the kidney, the FDA said in a news release.

Afinitor is among a class of drugs called kinase inhibitors, which thwart the growth of tumors by blocking cells' ability to communicate. Approval was granted for use in people with advanced renal cell cancer who have tried other kinase inhibitors, including Sutent (sunitinib) or Nexavar (sorafenib).

A clinical trial evaluating Afinitor's safety and effectiveness was halted early after clinical data showed the drug delayed the growth or spread of kidney tumors, compared to people who did not take the drug, the agency said. In half of the people who received Afinitor, disease progression was delayed approximately five months.

Common side effects of Afinitor observed during the trial included swelling of the mouth, weakness, diarrhea, loss of appetite, fluid buildup in the arms and legs, and shortness of breath.

More information

The FDA has more about this drug's approval.

-- Scott Roberts

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