Novartis’ Afinitor Gets FDA Clearance for Advanced Kidney Cancer

By Anna Boyd
15:07, March 31st 2009
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Novartis’ Afinitor Gets FDA Clearance for Advanced Kidney Cancer

The Food and Drug Administration on Monday approved Novartis AG’s Afinitor for advanced kidney cancer in patients whose cancers continue growing, even after being treated with other drugs. 

Kidney cancer also known as renal cell carcinoma killed more than 13,000 people in the United States last year, according to data coming from the American Cancer Society.
 
The approval follows tests showing that patients treated with Afinitor lived more than twice as long without tumor growth as those who didn't receive the drug. The study showed the drug delayed tumor growth nearly 5 months, compared with less than two months for patients not taking the drug.
 
Among side effects of the drug are mouth inflammation, weakness, diarrhea, loss of appetite, fluid buildup in the limbs, shortness of breath, coughing, nausea, vomiting, rash and fever, according to the Food and Drug Administration. Moreover, half of the patients treated with it developed anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.
 
Afinitor works by blocking a protein that helps cancer cells divide and grow. The drug was approved for patients who have already taken Pfizer Inc.'s Sutent and Bayer's Nexavar.
 
Norvartis is also testing Afinitor in gastric cancer, breast cancer, lymphoma, a type of liver cancer, and tuberous sclerosis, a rare genetic disease.
 
For the moment, the company has submitted the drug for approval in the European Union, Japan and elsewhere.



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