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Cancer Drug Information

  • Updated: 07/03/2013

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FDA Approval for Imiquimod

Brand name(s): Aldara®

  • Approved for superficial basal cell carcinoma

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for imiquimod (Aldara® topical cream, made by 3M Pharmaceuticals). This product is currently approved for the treatment of actinic keratosis and external genital warts. The FDA has now approved 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.

Superficial basal cell carcinoma is usually treated by surgical removal. Imiquimod 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 imiquimod for sBCC should have regular follow-up visits after treatment to make sure the skin cancer is completely treated.

The safety and effectiveness of imiquimod 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 imiquimod 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.

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 imiquimod for treatment of sBCC on the body, neck, arms or legs, but not for treatment of sBCC on the face.

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

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.