The FDA has approved a new drug to treat a rare and slow-growing type of skin cancer.
The agency approved Zolinza capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of lymphoma that affects the skin.
The drug is approved for treatment when the disease gets worse, persists, or comes back during or after treatment with other medicines.
Researchers say about three in a million people are diagnosed with the skin cancer each year, mostly middle-aged men.
Zolinza was approved as part of FDA's Orphan Drug program, which offers companies financial incentives to develop medicines for diseases that affect fewer than 200,000 Americans a year.
Benefits and Risks
The safety and effectiveness of Zolinza were evaluated in two clinical trials involving 107 people with CTCL, who received the drug after their disease came back or other treatments had failed.
Of patients receiving the drug, 30% saw improvement, with the benefit lasting an average of 168 days.
The most common serious side effects of Zolinza were blood clots in the lungs (pulmonary embolism), dehydration, deep vein thrombosis (blood clots in deep veins) and anemia.
Other side effects included diarrhea, nausea, anorexia, vomiting, constipation, fatigue, chills, and taste disorders.
The drug has not been studied in pregnant women, but animal studies suggest Zolinza may harm the fetus if used during pregnancy.
Zolinza is manufactured by Pantheon Inc. for Merck & Co. Inc.
By Jennifer Warner, WebMD Medical News, October 11, 2006