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FDA Approves New Melanoma Treatment

Posted: March 28, 2011

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Yervoy is a biologic therapy. It's a kind of man-made antibody (a monoclonal antibody) that blocks a crucial switch on immune cells called CTLA-4. Cancers use this switch to turn off the body's anticancer immune responses.

Most drugs like this come with possibly severe side effects, and Yervoy is no exception. The drug can provoke powerful autoimmune reactions in which the immune system attacks normal cells in the body. In clinical trials, nearly 13% of patients taking Yervoy had severe or fatal autoimmune reactions.

Common side effects resulting from such autoimmune reactions linked to Yervoy include fatigue, diarrhea, skin rash, hormone deficiencies, and colitis (inflammation of the intestines).

Because of these unusually severe side effects, Bristol-Myers has agreed to establish what the FDA calls a risk evaluation and mitigation strategy (REMS) to help doctors avoid and manage adverse reactions to Yervoy.

By Daniel J. DeNoon, WebMD, March 25, 2011