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FDA Approves
New Kidney Cancer Drug
WASHINGTON, May 31 (UPI) --
The U.S. Food and Drug Administration
announced approval of Torisel (temsirolimus) for the treatment
of a certain type of advanced kidney cancer.
The drug was approved for treatment of renal cell carcinoma
based on a study that showed use of Torisel prolonged patient
survival. The drug is an enzyme inhibitor -- a protein that
regulates cell production, cell growth and cell survival.
"We have made significant advances in the battle against
kidney cancer," said Dr. Steven Galson, director of the
FDA's Center for Drug Evaluation and Research. "Torisel
is the third drug approved for this indication in the past
18 months and one that shows an increased time in survival
for some patients."
The approval of Torisel follows the December 2005 approval
of Nexavar (sorafenib), which was based on a delay in progression
of the disease. In January 2006, Sutent (sunitinib) received
accelerated approval based on durable response rate, or tumor
size reduction, and was later demonstrated to delay tumor
progression.
Renal cell carcinoma, diagnosed in about 51,000 people annually
in the United States, accounts for about 85 percent of all
U.S. adult kidney cancer.
Torisel is manufactured by Philadelphia-based Wyeth Pharmaceuticals
Inc.
Copyright 2007 by United Press International.
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