FDA Approves Zolinza for Cutaneous T-cell Lymphoma

ROCKVILLE, Md., Oct. 9 -- The FDA has approved Zolinza (vorinostat) capsules as second-line therapy for cutaneous T-cell lymphoma that is refractory or recurrent.

The Zolinza approval was granted as part of the FDA's Orphan Drug program, which offers companies financial incentives to develop medications for diseases affecting fewer than 200,000 American patients a year.

The annual incidence of cutaneous T-cell lymphoma is about three per million. It is approximately twice as common in men as in women and blacks have twice the incidence of whites. The average age at diagnosis is 50 to 55.

Zolinza was evaluated in two clinical trials of 107 patients with cutaneous T-cell lymphoma who received Zolinza after their disease had recurred following other treatments.

A response, defined by improvements on a scale that scores skin lesions, occurred in 30% 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.

Other common side-effects included diarrhea, nausea, anorexia, vomiting, constipation, fatigue, chills, and taste disorders.

Zolinza has not been studied in pregnant women, but results of animal studies suggest that the drug may lead to fetal harm.

Zolinza is manufactured by Pantheon, Inc., in Mississauga, Ontario, for Merck in Whitehouse Station, N.J.