U.S. health regulators on Monday approved a pill from the Genentech unit of Swiss drug maker Roche to treat an advanced form of the most common form of skin cancer, basal cell carcinoma (BCC).
The indication for the drug Erivedge is approved for use by adults whose cancer cannot be effectively treated with surgery or radiation or whose disease has metastasized or relapsed to other parts of the body after surgery.
Erivedge, which was co-developed by Curis Inc., is the first drug to be approved by the Food and Drug Administration that is used to treat advanced forms of the most common skin cancer. The drug was given a green light more than a month ahead of the expected March 8 decision date.
Erivedge, chemically known as vismodegib, is taken orally once a day and is designed to stop abnormal signaling in the Hedgehog pathway, an underlying molecular driver of BCC. The drug works by binding and inhibiting Smoothened, a trans-membrane protein involved in Hedgehog signal transduction.
Genetech said that the drug will be made available within one to two weeks.
"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 is expected to cost about $7,500 a month and is estimated to be $75,000 for a 10-month course of treatment, Curis Inc. said in a regulatory filing.
Curtis earned a $10 million milestone payment from Roche as a result of the approval and is entitled to royalty payment on the sales of the drug.
Erivedge has yet to be approved in Europe.
Of the patients with BCC receiving Erivedge in clinical studies testing the drug’s effectiveness, 30 percent of the participants experienced partial shrinkage and 43 percent of patients experienced complete or partial disappearance of basal cell carcinoma lesions after treatment.
Basal cell carcinoma is a slow-growing and painless form of skin cancer that begins in the top layer of the skin and develops in areas that are frequently exposed to sunlight or ultraviolet radiation. An estimated 2.8 million Americans each year are affected by Basal cell carcinomas. According to the Skin Cancer Foundation, BCCs are usually non-life threatening but can be very disfiguring if they continue to grow.
The most common side effects, exhibited in at least 10 percent of clinical trial participants, were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.
FDA has approved Erivedge with a warning alerting patients and health-care providers of the potential risk of death or severe birth defects to a fetus. Pregnancy status must be verified before starting the Erivedge treatment, the FDA said.