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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-162
October 6, 2006

Media Inquiries:
Megan Moynahan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

FDA Approves New Drug for Skin Cancer, Zolinza

The U.S. Food and Drug Administration (FDA) today approved Zolinza (vorinostat) capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines.

Zolinza was approved as part of FDA's Orphan Drug program, which offers companies financial incentives to develop medications for diseases affecting fewer than 200,000 American patients a year.  Every year in the United States, about three in every one million people are diagnosed with CTCL.  The majority of people with CTCL are men with an average age of 50 years.

"This approval is another example of the benefits of modern research that's focused on providing prescribers with safe and effective therapies for all types of cancer, including those that affect relatively few patients," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research.

Evidence of Zolinza's safety and effectiveness was developed in two clinical trials with 107 CTCL patients who received Zolinza after their disease had recurred following other treatments. A response, defined by improvements on a scale that scores skin lesions, occurred in 30 percent of patients who received Zolinza and lasted an average of 168 days.  The most common serious adverse events were pulmonary embolism (blood clot in the lungs), dehydration, deep vein thrombosis and anemia. The most common other adverse events were gastrointestinal symptoms (including diarrhea, nausea, anorexia, vomiting and constipation); fatigue; chills; and taste disorders.

Zolinza has not been studied in pregnant women, but results of animal studies suggest that the drug may cause fetal harm when administered during pregnancy.

Zolinza is manufactured by Pantheon, Inc., in Mississauga, Ontario, Canada, for Merck & Co., Inc., Whitehouse Station, N.J.

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