FDA approves Roche skin cancer drug

U.S. health regulators on Monday approved Roche’s pill to treat an advanced form of the most common form of skin cancer, known as basal cell carcinoma.

The drug, Erivedge, which was co-developed by Curis Inc, was given a green light by the Food and Drug Administration more than a month ahead of the expected March 8 decision date. It was approved for use by adults whose cancer cannot be treated with surgery or radiation or whose disease has spread to other parts of the body or returned following surgery.

Erivedge, known chemically as vismodegib, is the first drug to gain FDA approval for advanced basal cell carcinoma. Curis, which earned a $10 million milestone payment as a result of the approval, is entitled to royalty payments on sales of the drug.

“Today’s approval provides a new treatment for people with advanced basal cell carcinoma who, until now, had no approved medicines to help shrink disfiguring or potentially life-threatening lesions,” Hal Barron, Roche chief medical officer, said in a statement.

The drug, which is taken once a day, is expected to cost about $7,500 a month, with an estimated 10-month course of treatment totaling about $75,000, Curis said in a regulatory filing.

Roche is awaiting an approval decision on the drug in Europe.

Basal cell carcinoma is generally a slow-growing and painless form of skin cancer that starts in the top layer of the skin and develops on areas that are regularly exposed to sunlight or other ultraviolet radiation.

Erivedge works by inhibiting a signaling pathway that is active in most basal cell cancers and only in a few normal tissues, such as hair follicles.

The drug was approved with a warning alerting patients and health-care professionals of the potential risk of death or severe birth effects to a fetus. Pregnancy status must be verified prior to the start of Erivedge treatment, the FDA said.

Curis shares were down 16 cents, or 3 percent, at $5.02 on Nasdaq. Roche shares closed off 1.2 percent in Switzerland.

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(Reuters)