FDA approves treatment for rare cancer

Published: Nov. 9, 2009 at 4:47 PM

WASHINGTON, Nov. 9 (UPI) -- The U.S. Food and Drug Administration says it has approved a new treatment for patients with a rare form of cancer known as Cutaneous T-cell Lymphoma.

The FDA says it has approved the use of Istodax (romidepsin), an injectable medication for the slow-growing cancer of infection-fighting white blood cells called T-lymphocytes. Most cases start with dry skin, red rash and itching that can become severe. The skin may develop tumors that can become ulcerated, causing infection. In some cases, Cutaneous T-cell Lymphoma spreads to the blood, lymph nodes, or internal organs.

FDA officials said Istodax interferes with processes required for cell replication. It is intended to be used in patients when the cancer becomes worse or returns after at least one other type of chemotherapy has been used.

"This approval demonstrates FDA's commitment to the development and approval of drugs for rare and uncommon diseases," said Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products.

Istodax is marketed by Gloucester Pharmaceuticals Inc. of Cambridge, Mass.

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