U.S. FDA approves new skin cancer medicine

U.S. FDA approves new skin cancer medicine

2012-01-31 17:09:44 GMT+7 (ICT)

WASHINGTON, D.C. (BNO NEWS) -- The United States Food and Drug Administration (FDA) on Monday announced the approval of a drug to treat one of most common types of skin cancer.

The FDA approved Erivedge (vismodegib), reviewed under the agency's priority review program and ahead of the March 8 prescription user fee goal date, to treat adult patients with basal cell carcinoma, the most common type of skin cancer.

The drug, however, is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

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

Erivedge is the first FDA-approved drug for metastatic basal cell carcinoma and was reviewed under the FDA's priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment.

"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

"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," Pazdur added.

The safety and effectiveness of Erivedge was evaluated in a single, multi-center clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma. The clinical study's primary endpoint was objective response rate (ORR) or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment.

Of the patients with metastatic disease receiving Erivedge, 30 percent experienced a partial response and 43 percent of patients with locally advanced disease experienced a complete or partial response, the FDA said.

Erivedge, which is a pill taken once a day, works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.

The most common side effects observed in patients treated with Erivedge 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.

The FDA said Erivedge is being approved with a boxed warning alerting patients and health care professionals of the potential risk of death or severe birth effects to a fetus. Also, pregnancy status must be verified prior to the start of Erivedge treatment. Male and female patients should be warned about these risks and the need for birth control, the FDA cautioned.

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