New Skin Cancer Drug Zolinza Approved
Zolinza Treats Rare Form of Lymphoma That Affects Skin
Oct. 11, 2006 - 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
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
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.