Prescriptions Blog: F.D.A. Approves Drug for an Advanced Skin Cancer

The first drug for an advanced form of the most common type of skin cancer won approval from the Food and Drug Administration on Monday.

The drug, Erivedge, made by Genentech, was approved for adults with basal cell carcinoma that has spread elsewhere in the body or those who are not candidates for the surgery or radiation ordinarily used to treat the disease.

Basal cell carcinoma is usually a slow-growing and painless form of cancer that develops on skin frequently exposed to the sun, like on the face, according to the F.D.A. If confined to a small location on the skin, it is generally considered curable by surgery and radiation treatment.

In rare cases, however, the tumors cannot be treated that way. In some cases, known as locally advanced disease, they invade nearby tissues and can become disfiguring. In other cases, they become metastatic, spreading elsewhere in the body.

The F.D.A. said in a news release that the approval was based on an analysis of 96 patients in a clinical trial with locally advanced or metastatic basal cell carcinoma. Some 30 percent of the patients with metastatic disease experienced a partial shrinkage of their tumors. For the patients with locally advanced disease, 43 percent experienced either a complete or partial shrinkage.

There was no control group getting a placebo in the trial, and the F.D.A. emphasized that it had approved the drug after a speedy review and before its March 8 deadline.

The F.D.A. has been under pressure from some patient advocates who contend that it demands too much data to approve drugs for cancer, potentially allowing people to die. Other advocates,

Read more: http://feeds.nytimes.com/click.phdo?i=1e1619d49e7f455fc4f08b23f390b8aa

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