FDA approves imiquimod for the treatment of superficial basal cell carcinoma

Journal of Drugs in Dermatology, Sept-Oct, 2004

The Food and Drug Administration announced the approval of a new indication for Aldara (imiquimod) topical cream. Aldara cream is manufactured by 3M Pharmaceuticals of St. Paul, Minnesota. Although its exact mechanism of action is unknown, it has been shown to induce production of interferon and other cytokines in human peripheral blood mononuclear cells and induce a local immune response. This product is currently approved for the treatment of actinic keratosis and external genital warts. On July 15, 2004, the FDA approved its use for the treatment of superficial basal cell carcinoma (sBCC) on body locations, excluding the face.

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

Superficial basal cell carcinoma is usually treated by surgical removal. The use of Aldara is recommended for the treatment of sBCC only when surgery is medically less appropriate, because the chances of effectively treating sBCC are 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 most frequently reported adverse effect of imiquimod for this indication is skin reaction at the treatment site. This can include redness, swelling, blistering, peeling, pruritus, and burning.

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