The U.S. Food and Drug Administration approved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma, according to a statement released Wednesday by FDA.
Torisel, which is manufactured by Philadelphia-based Wyeth Pharmaceuticals, Inc., was approved based on a study that showed use of the drug prolonged survival of patients with renal cell carcinoma. The drug is an enzyme inhibitor, a protein that regulates cell production, growth and survival.
Torisel is the third drug approved for battling against kidney cancerin in the past 18 months. In December 2005, FDA approved Nexavar (sorafenib), which was based on a delay in progression of 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.
The most common adverse reactions, occurring in at least 30 percent of Torisel-treated patients, were rash, fatigue, mouth sores, nausea, edema, and loss of appetite. The most common laboratory abnormalities were high blood sugar, elevated blood lipids and triglycerides, elevated liver and kidney blood tests, and low red cell, white cell, and platelet counts.
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.
Source: Xinhua