New drug Erivedge approved for most common skin cancer

Consumer Reports News: January 31, 2012 03:08 PM

The drug Erivedge has been approved by the Food and Drug Administration to treat adult patients with an advanced form of the most common type of skin cancer—Basal cell carcinoma.

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

Made by Genentech, Erivedge (vismodegib) is the first FDA-approved drug for metastatic basal cell carcinoma.

The drug was reviewed under the FDA's priority review program, which is an expedited six-month review of drugs that may offer major advances in treatment.

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

The Erivedge drug is a pill taken once a day and works by inhibiting the Hedgehog pathway, which 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 included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste.

In a press release, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research stated the following:

Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases. 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.

The safety and effectiveness of Erivedge was evaluated in a clinical study with 96 patients with locally advanced or metastatic basal cell carcinoma. 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.

Erivedge is being approved with a boxed warning alerting stating the potential risk of death or severe birth effects to a fetus.

FDA approves new treatment for most common type of skin cancer [FDA]

Maggie Shader

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