Imiquimod up for FDA approval to treat BCC, AK. (Phase III Trial Results).(basal cell carcinoma; actinic keratosis)

Publication: Skin & Allergy News

Publication Date: 01-JUL-03

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COPYRIGHT 2003 International Medical News Group

SEVILLE, SPAIN -- Imiquimad, a topical immune stimulator, showed efficacy for treating superficial basal cell carcinoma and actinic keratosis in phase III trials.

Based on these results, 3M, which makes imiquimod (Aldara), has filed supplemental new drug applications with the FDA to expand the approved indications to include these two disorders.

The application for actinic keratosis was filed in May, and the application for superficial basal cell carcinoma was filed in June.

Imiquimod is already on the U.S. market with an indication for treating genital warts.

In two phase III trials, regular treatment with imiquimod for 6 weeks led to resolution of about 80% of superficial basal cell carcinomas in 364 treated patients, Dr. Amit C. Pandya reported at the Ninth World Congress on Cancers of the Skin.

In two additional studies with a total of 436 patients, regular treatment with imiquimod for...

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