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New Treatment Approved for Most Common Type of Skin Cancer


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The U.S. Food and Drug Administration has approved Genentech’s™ (vismodegib) for the treat­ment of adults with basal cell carcinoma (the most common type of skin cancer) that has spread to other parts of the body, that has come back after surgery, or that their healthcare provider decides can­not be treated with surgery or radiation. Erivedge, a capsule that is taken orally once a day, is the first FDA-approved medicine for people with advanced forms of basal cell carcinoma.

The safety and effectiveness of Eri­vedge was evaluated in a clinical study of 96 people with locally advanced or meta­static basal cell carcinoma. Of the study participants with metastatic disease re­ceiving Erivedge, 30 percent experienced a partial response, and 43 percent of par­ticipants with locally advanced disease experienced a complete or partial response.

Erivedge is being approved with a boxed warning alerting users and healthcare professionals of the potential risk of severe birth defects or death to a fetus. Pregnancy status must be verified prior to the start of Erivedge treatment. Both males and females starting this drug should be warned about these risks and the need for birth control.

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This article was published in Coping® with Cancer magazine, March/April 2012.

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