Roche’s skin cancer drug Erivedge gets FDA nod

By Dr. Ananya Mandal, MDJan 31 2012

The Food and Drugs Administration (FDA) this Monday approved a pill that treats the most common type of skin cancer, basal cell carcinoma.

The once-a-day oral drug called Erivedge is made by Genentech, a unit of Swiss drugmaker Roche. Erivedge is intended to treat locally advanced cancer for patients who are not candidates for surgery or radiation, and for patients whose cancer has spread to other parts of the body.

The drug is chemically known as vismodegib. Vismodegib is the first FDA-approved drug for metastatic basal cell carcinoma, the most common form of skin cancer. Vismodegib — taken once a day — inhibits the Hedgehog pathway, which is active in most basal cell cancers.

“Our understanding of molecular pathways involved in cancer, such as the hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.”

Genentech said Erivedge is the first drug approved to treat advanced basal cell carcinoma. It said the drug will be available within one to two weeks. Curis Inc. of Lexington, Mass., which collaborated with Genentech on the drug, is getting a $10 million payment from Genentech now that the drug has been approved. The drug 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.

The approval comes ahead of schedule, as the FDA previously said it would make a decision on Erivedge by March 8. The drug was given a fast six-month review because there are no approved treatments for basal cell carcinoma. The approval was based on results of a single, multicenter clinical study of 96 patients with locally advanced or metastatic basal cell carcinoma. The primary endpoint was objective response, defined as complete or partial shrinkage or disappearance of cancerous lesions after treatment. Thirty percent of patients with metastatic disease who received vismodegib experienced partial response, and 43% of patients with locally advanced disease experienced complete or partial response, according to the FDA.

The label would carry a warning that it is linked to fetal death and severe birth defects when it is used by pregnant women. The most common side effects of Erivedge include muscle spasms, hair loss, weight loss, diarrhea, fatigue, changes or loss in sense of taste, decreased appetite, constipation, and vomiting.

“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.
Approval is awaited 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.