FDA OKs New Kidney Cancer Drug

Afinitor Approved for Advanced Kidney Cancer That Progresses Despite Other Treatment

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

April 2, 2009 -- The FDA has approved a new drug called Afinitor to treat advanced renal cell carcinoma after other treatments fail. Renal cell carcinoma is the most common type of kidney cancer.

Afinitor (everolimus) is taken orally. It's part of a class of drugs called kinase inhibitors, which interfere with cell communication to prevent tumor growth.

The FDA approved Afinitor for advanced renal cell carcinoma patients who have already tried another kinase inhibitor -- Sutent or Nexavar.

The FDA based its decision on a clinical trial that was discontinued when interim results showed that the growth or spread of the tumor was delayed in patients taking Afinitor.

In that trial, half of the patients taking Afinitor also had slower worsening of their kidney cancer; their disease progressed after about five months, compared to two months in patients who didn't receive the drug.

The most frequent side effects in the trial included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever.

Lab tests also showed that at least half of all patients experienced anemia, low white blood cell counts, high cholesterol, high triglycerides, and high blood sugar, according to the FDA.

Afinitor is made by the drug company Novartis.

SOURCES: News release, FDA. News release, Novartis.

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