2012 new type of drug,the US Food and Drug Administration approved a new type of drug to treat adult patients with advanced basal-cell carcinoma, the most common type of skin cancer.
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 review took into account a study that tested the safety and effectiveness of Erivedge. The study was a single, multi-center clinical trial in 96 patients whose basal cell carcinoma was either locally advanced or metastatic.
The most common side effects were hair loss, muscle spasms, weight loss, fatigue, reduced appetite, distorted sense of taste, loss of taste function in the tongue, nausea, constipation, vomiting, and diarrhea.
The drug must carry a Boxed Warning telling patients and doctors about the potential risk of death or severe birth defects to an unborn child.
Women must check they are not pregnant before starting on Erivedge, and patients should be warned of these risks and the need for birth control before starting on the drug, said the FDA in a statement.
Basal cell carcinoma is a slow growing, painless cancer that starts in the epidermis, the top layer of skin. It usually starts in places that are regularly exposed to the sun or UV light.
The drug's generic name is vismodegib & was developed by the US part of Roche Holding AG. It will be sold in the US by Roche's South San Francisco-based Genentech under the brand name Erivedge.
