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FDA Approves Melanoma Immunotherapy Drug

Sun (NOAA)

(NOAA)

The U.S. Food and Drug Administration (FDA) approved Yervoy — ipilimumab — to treat patients with late-stage metastatic melanoma, a dangerous type of skin cancer. Yervoy is marketed by Bristol-Myers Squibb, in Princeton, New Jersey.

Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

Yervoy is a monoclonal antibody, administered intravenously, that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. That molecule is believed to help slow down or turn off the body’s immune system that fights cancer cells. Yervoy helps the immune system recognize, target, and attack cells in melanoma tumors.

Yervoy’s safety and effectiveness were established in an international study of 676 patients with melanoma, who had also stopped responding to other approved or commonly used treatments. In addition, participants had disease that had spread or that could not be surgically removed.

The study measured overall survival, as the length of time from when this treatment started until a patient’s death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone. Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

Common side effects can result from autoimmune reactions associated with Yervoy use. They include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy.

When severe side effects occurred, says FDA, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.

Due to the unusual and severe side effects associated with Yervoy, FDA approved the therapy with a strategy to inform health care professionals about these risks. A medication guide will also be provided to patients to inform them about the therapy’s potential side effects.

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