-- Scott Roberts
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
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
Researchers evaluated the safety and effectiveness of Erivedge
in a clinical study of 96 people with locally advanced or
metastatic 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 ago."
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 treatable.
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
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.
Skin Cancer Foundation has details about basal
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