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Penulis Topik: FDA approves Wyeth kidney cancer drug  (Dibaca 3201 kali)

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FDA approves Wyeth kidney cancer drug
« pada: Juni 01, 2007, 01:05:23 AM »
FDA approves Wyeth kidney cancer drug

Wed May 30, 5:54 PM ET

WASHINGTON (Reuters) - U.S. health regulators on Wednesday approved Wyeth's drug Torisel for patients with an advanced form of kidney cancer called renal cell carcinoma, saying it significantly helped them live longer.

The drug, known chemically as temsirolimus, is the third such therapy approved since late 2005 for the disease -- the most common form of kidney cancer, the
Food and Drug Administration said.

In December 2005, the FDA cleared Bayer's Nexavar, or sorafenib. In January 2006, Pfizer Inc.'s Sutent, or sunitinib, also won approval.

A spokeswoman for Wyeth had no immediate comment but said the company would release a statement later on Wednesday.

Shares of the drugmaker earlier closed down less than 1 percent at $57.50 on the
New York Stock Exchange.

The FDA said studies of Torisel showed that patients who took it alone lived longer overall than those who took it with the cancer drug interferon or a combination of the two.

Torisel patients survived for about 10.9 months compared with 7.3 months for those taking just interferon. Combining the two drugs "did not result in a significant increase in overall survival when compared with interferon alone," the FDA added.

Common side effects with Torisel included rash, fatigue, mouth sores and nausea, among others, the FDA said. High blood sugar, elevated blood lipids and low blood cell counts were also found.

About 51,000 U.S. cases of renal cell carcinoma are diagnosed each year, according to the agency.




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