First Drug Ok'd to Combat Spreading Basal Cell Skin Cancer

Posted: January 30, 2012 at 9:52 pm

MONDAY, Jan. 30 (HealthDay News) — The U.S. Food and
Drug Administration on Monday approved a drug to treat the most
common form of skin cancer, basal cell carcinoma.

Erivedge (vismodegib) is the first drug sanctioned in the
United States to treat basal cell skin cancer that has
metastasized, or spread. The once-daily pill is also designed
for cases deemed unsuitable for surgery or radiation, the
agency said in a news release.

This usually slow-growing, painless form of cancer starts in
the epidermis, the top layer of skin. Frequent exposure to
sunlight and other forms of ultraviolet radiation are the
typical causes, the FDA said.

Researchers evaluated the safety and effectiveness of Erivedge
in a clinical study of 96 people with locally advanced or
cancer. Of those with metastatic disease, 30 percent had
at least a partial response to the drug, while 43 percent of
people with locally advanced basal cell had at least a partial

One specialist welcomed the drug's approval.

“Eviredge is an amazing revolutionary approach to treating skin
cancer,” said Dr. Michele Green, dermatologist at Lenox Hill
Hospital in New York City. “I have many patients who are
elderly and infirm for whom getting surgery is a major ordeal.
Molecular biology has advanced to the point where such an
important advance in therapy was unthinkable even a few years

Skin cancer is the most commonly diagnosed cancer in the United
States, and it is estimated that one in five Americans
will develop it in their lifetime. Caught early, it is highly

The most frequently cited side effects of Erivedge included
muscle spasms, hair loss, weight loss, nausea, diarrhea,
fatigue, distorted sense of taste, decreased appetite,
constipation and vomiting.

Because of the potential risk for death or severe birth defects
to a fetus, the drug will be packaged with a label warning, and
doctors will not prescribe it to women who are pregnant, the
agency said. Men and women will be advised to use birth control
while taking the pills.

Erivedge, marketed by San Francisco-based Genentech, won
expedited approval under a priority review program for drugs
that may represent a major treatment advance.

More information

The Skin Cancer Foundation has details about
basal cell.

First Drug Ok'd to Combat Spreading Basal Cell Skin Cancer

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