Cutaneous T-cell lymphoma: US FDA approval of Zolinza

The United States Food and Drug Administration has approved Zolinza (generic name Vorinostat, also known as SuberoylAnilide Hydroxamic Acid or SAHA) ) capsules for the treatment of advanced cutaneous T-cell lymphoma (CTCL), a lymphoma of the skin.

Zolinza is the first in a new class of anti-cancer therapies called histone deacetylase (HDAC ) inhibitors. Histone deacetylation is thought to be a mechanism for silencing some tumor suppressor genes and other genes responsible for cell cycle progression, cell proliferation, programmed cell death (apoptosis), and differentiation.

Zolinza is approved as part of FDA's Orphan Drug program. Every year in the United States, about three in every one million people are diagnosed with cutaneous T-cell lymphoma. The majority of people with cutaneous T-cell lymphoma are men with an average age of 50 years.

Evidence of Zolinza's effectiveness was developed in two clinical trials with 107 cutaneous T-cell lymphoma patients who received Zolinza after their disease had recurred following other treatments. A response occurred in 30 percent of patients who received Zolinza and lasted an average of 168 days.

The most common serious adverse events were pulmonary embolism, dehydration, deep vein thrombosis and anemia. The most common other adverse events were gastrointestinal symptoms ( including diarrhea, nausea, anorexia, vomiting and constipation ); fatigue; chills; and taste disorders.

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