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FDA-Approved Drugs

FDA-Approved Drugs

Zolinza (vorinostat)

FDA approved October 2006

This drug is approved 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 was approved as part of FDA's Orphan Drug program, which offers companies financial incentives to develop medications for diseases affecting fewer than 200,000 American patients 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 percent of patients who received Zolinza and lasted an average of 168 days.  The most common serious adverse events were pulmonary embolism (blood clot in the lungs), 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.

Zolinza has not been studied in pregnant women, but results of animal studies suggest that the drug may cause fetal harm when administered during pregnancy.

Aldara (imiquimod)

FDA approved July 1997

This topical cream was initially approved for the treatment of actinic keratosis and external genital warts. Now, it's approved for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

This type of skin cancer is diagnosed by a healthcare provider after biopsy and is different from other types of skin cancer including other types of basal cell carcinoma.

Superficial basal cell carcinoma is usually treated by surgical removal. Aldara should be used for treatment of sBCC only when surgery is medically less appropriate, because the chances of effectively treating sBCC are generally greater with surgery. Patients treated with Aldara for sBCC should have regular follow-up visits after treatment to make sure the skin cancer is completely treated.

The safety and effectiveness of Aldara were established in two double-blind controlled studies with approximately 364 patients. In these studies, 75 percent of patients (139/185) who had their sBCC treated with Aldara had no evidence clinically or on repeat biopsy of their sBCC at 12 weeks after finishing treatment. In a separate long-term study involving 182 patients, 79 percent of patients had no evidence of their sBCC at two years after finishing treatment.

Most patients using Aldara Cream for the treatment of sBCC experienced skin reactions at the treatment site, which include redness, swelling, a sore or blister, peeling, itching, and burning.




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