FDA Approves Merck’s Skin Cancer Drug

The FDA has approved Merck’s Zolinza capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. Zolinza is manufactured by Patheon, Inc. in Mississauga, ON.

Zolinza was approved as part of FDA’s Orphan Drug program, which offers companies incentives to develop medications for diseases affecting fewer than 200,000 Americans a year.

Evidence of Zolinza’s safety and effectiveness was developed in two clinical trials with 107 CTCL patients 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.