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FDA Approves New Drug for Intractable Skin Cancers

Zolinza targets cutaneous T-cell lymphoma affecting fewer than 200,000 U.S. patients annually

MONDAY, Oct. 9 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new skin cancer drug, Zolinza, for the treatment of persistent cutaneous T-cell lymphoma. Zolinza (vorinostat) is made by Pantheon, Inc., of Mississauga, Ontario, Canada, for Merck & Co., Inc.

The FDA approved Zolinza for treatment of skin cancer that worsens, persists or returns despite treatment with other drugs. The new drug was approved under the FDA's Orphan Drug program, which gives drugmakers a financial boost to make drugs for ailments that affect fewer than 200,000 U.S. patients annually, according to an FDA statement.

Two studies of 107 cutaneous T-cell lymphoma patients treated with Zolinza after other drugs failed showed that 30 percent of patients on Zolinza experienced improvement lasting 168 days on average. Severe side effects most often experienced ranged from dehydration to pulmonary embolism. Less severe side effects ranged from fatigue to constipation.

"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," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.

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