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FDA Approves Drug for Basal Cell Carcinoma

Article date: February 1, 2012

By Stacy Simon

The US Food and Drug Administration (FDA) has approved the first drug specifically for basal cell carcinoma, the most common type of skin cancer. The drug is called vismodegib (Erivedge) and is a pill that is taken once a day. It’s approved for the treatment of patients whose basal cell carcinoma has spread from where it started, and for patients who can’t be treated with surgery or radiation.

The FDA based its decision on a clinical trial of 96 patients with basal cell carcinoma that had spread or couldn’t be removed and whose cancers were growing even after the standard treatments of surgery and radiation. In the trial, tumors shrank in 30% of patients with cancer that had spread to other parts of the body. Tumors shrank or disappeared in 43% of patients with cancer that had grown out of control in the area where it had started.

This drug will give another treatment option to patients with basal cell carcinoma that is hard to treat. Most of the time, basal cell carcinoma is treated with surgery, and in the rare cases when it spreads, with radiation. But the patients in the clinical trial were not able to have the standard treatment either because of health problems or because they had been treated previously, and when their cancer came back the treatment didn’t work anymore.

Erivedge is the first drug that targets something called the Hedgehog pathway, a process that is important in growth and development in many of the body’s cells. In basal cell carcinoma, the process is often abnormal. The drug is also being tested in pancreatic cancer and a certain type of brain cancer.

Erivedge was approved under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

Side effects include muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, changes or loss of taste, decreased appetite, constipation, and vomiting. The drug can harm babies born to women taking the drug while pregnant, or who become pregnant from a partner who is taking the drug.

The drug is marketed by Genentech.

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