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FDA Approves Superficial Basal Cell Carcinoma Indication for Imiquimod

ST. PAUL, MN -- July 15, 2004 -- The Food and Drug Administration (FDA) today announced the approval of a new indication for Aldara (imiquimod) topical cream. This product is currently approved for the treatment of actinic keratosis and external genital warts. Today, FDA is approving its use 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.

“Skin cancer is one of the most prevalent forms of cancer,” said Lester M. Crawford, Acting FDA Commissioner. “Today’s approval provides another example of FDA’s commitment to bringing new cancer therapies to the market.”

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% 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% of patients had no evidence of their sBCC at two years after finishing treatment.

Skin cancer can occur anywhere on the body, but it is most common on skin that has been exposed to sunlight. The most common type of skin cancer is basal cell carcinoma, affecting at least 800,000 Americans each year. The superficial type of basal cell carcinoma usually occurs on the arms, legs or on parts of the body such as the chest or back. Now FDA is approving Aldara for treatment of sBCC on the body, neck, arms or legs, but not for treatment of sBCC on the face.

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.

Aldara Cream is manufactured by 3M Pharmaceuticals of St. Paul , Minn.

Source: The Food and Drug Administration

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