Zolinza Capsules For Treating Rare Skin Cancer

By: Catherine Yeh for Body1

Cutaneous T-cell lymphoma (CTCL) patients now have a new treatment option – in the form of a pill.

Late last year, the U.S. Food and Drug Administration (FDA) approved Zolinza capsules for the treatment of T-cell lymphoma, a rare type of cancer that affects the skin through the T-cells or white blood cells. Zolinza, also referred to as a histone deacetylase (HDAC) inhibitor, causes a chemical change in the body which halts tumor cell division. In some cancer cells, genes that control normal cell activity are not activated due to excess amounts of the HDAC enzyme. Zolinza reduces HDAC activity, which in turn activates cancer-catching genes.

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Fair people with light skin and hair, and blue eyes are most at risk for skin cancers. Also, those who work outside or people who have had sunburns early in life need to be extra cautious according to the U.S. Centers for Disease Control. Pundits on all sides of the debate advocate avoiding the sun when the harshest rays will hit: between 10 a.m. and 3 p.m. Healthcare providers across the board also do not recommend the use of tanning beds or sun lamps. Be vigilant and catch signs of skin cancer early. Check your skin for any moles or marks that have changed. Consider seeing a dermatologist yearly.

“With today’s FDA approval of Zolinza, there is now an effective new option in the fight against cutaneous manifestations of T-cell lymphoma and other failed cancer treatment options,” said Elise Olsen, M.D., director for the CTCL Clinic and Research Center at Duke University. Dr. Olsen was also the lead investigator for one of the studies that lead to the FDA approval of Zolinza.

Zolinza was tested in two clinical trials for safety and effectiveness. A total of 107 CTCL patients were evaluated. Eighty-six patients received a 400 mg dosage once daily. These patients received Zolinza following other failed treatment strategies. Effectiveness was measured by a skin lesion score index. Improvements on the scale were defined as Zolinza response. Thirty percent of the patients saw an improvement with lasting benefits. Side effects included pulmonary embolism, dehydration, deep vein thrombosis and anemia.

Patients should inform their physicians if they have a prior history of thromboembolic events before considering Zolinza. Drinking at least two liters of fluids per day is advised to avoid possible dehydration. Other side effects experienced by these patients included fatigue (52 percent), diarrhea (52 percent), nausea (41 percent), change in taste (28 percent), low platelet count (26 percent), anorexia (24 percent), weight loss (28 percent), and muscle spasm (20 percent). The drug was not studied in pregnant women. However, animal studies suggest that Zolinza may harm a fetus if taken during pregnancy.

Zolinza is generally a good option when other methods have failed. The standard dose is 400 mg, once a day with food. The dose may be lowered to 300 mg after five consecutive days, if the physician feels it is appropriate.

Zolinza was approved in part as a result of the FDA’s Orphan Drug program, whose goal is to promote the development of medications for rare diseases. According to the National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program (2006), there are about 1,500 new cases of CTCL each year. Or, three people per million. The disease is more common in men between the ages of 50 and 55 years.

Zolinza is manufactured by Pantheon Inc. for Merck & Co. Inc. If you would like to learn more about Zolinza, click here.

Last updated: 19-Mar-07