New Drug for Skin Cancer Approved

There seems to be some good news for people suffering from advanced basal cell carcinoma as the drug Erivedge has been approved by the FDA to treat this form of skin cancer. Developed by Roche Holding AG in the USA, this drug with the generic name vismodegib was passed by the FDA thought its priority fast-track program, where it only takes six months to review drugs that show promise of major advances in treatment.

Basal cell carcinoma is a slow growing and painless cancer that starts in the epidermis or upper layer of the skin, usually in areas that have been regularly exposed to the sun or UV light.  Erivedge works by inhibiting the Hedgehog pathway, and is a once a day oral medication. The Hedgehog pathway has been found to be active in most basal cell cancers, but only in a few normal tissues such as hair follicles.

This drug has been developed for patients who suffer from locally advanced basal cell carcinoma and are not having surgery or radiation therapy, and also for people whose cancer has metastasized (spread) to other parts of the body. This is the first FDA approved drug for metastatic basal cell carcinoma. The FDA while reviewing Erivedge looked at a study that tested the safety and effectiveness of this drug on 96 patients with local advanced or metastatic basal cell carcinoma. This multi center study found that 43% of patients with locally advanced disease and 30% with the metastatic form of the disease responded positively to the medication.

Dr Richard Pazdur, the Director of the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research at the FDA, felt that drugs can be developed more easily and faster to treat specific diseases once more is known about the hedgehog pathway and others that are important to the spread of cancers.

The most common side effects were hair loss, muscle spasms, weight loss, fatigue, reduced appetite, distorted sense or loss of taste, nausea, constipation, vomiting and diarrhea. This drug should not be used if you are pregnant or nursing. It is very important to check if you are pregnant before you begin this drug, and should use birth control while using the drug.

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