NCI Cancer Bulletin: A Trusted Source for Cancer Research NewsNCI Cancer Bulletin: A Trusted Source for Cancer Research News
October 24, 2006 • Volume 3 / Number 41 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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FDA Update

FDA Approves Vorinostat for Cutaneous T-Cell Lymphoma

The Food and Drug Administration (FDA) has approved vorinostat (Zolinza) capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of non-Hodgkin's lymphoma. The disease is a cancer of T cells, which are part of the lymph system. In CTCL, which affects an estimated 20,000 Americans each year, malignant T cells migrate to the skin and may be deposited there.

Vorinostat was approved for patients who have tried and failed other therapies. The drug is to be used when the disease persists, gets worse, or recurs during or after treatment with other medicines, according to the FDA.

Approval was based on two clinical trials involving 107 CTCL patients who received vorinostat after their disease had recurred following treatment. About 30 percent of patients responded to the drug, defined by measurable improvement in skin lesions; the response lasted 168 days on average.

Vorinostat is manufactured by Pantheon, Inc., of Mississauga, Ontario, for Merck.