FDA Approved Yervoy for Late-Stage Melanoma Treatment

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2011-03-26 11:32

As anticipated, the U.S. Food and Drug Administration (FDA) approved Yervoy (ipilimumab) yesterday for the treatment of patients with late-stage (metastatic) melanoma.

According to the National Cancer Institute, 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.

Yervoy (ipilimumab) is the first melanoma drug to receive FDA approval in 13 years. It was developed jointly by Medarex and Bristol-Myers Squibb.

When melanoma is discovered early, it can usually be cured with surgery alone, but once it spreads (metastasizes) throughout the body, treatment options are limited. Current drug therapy for melanoma includes dacarbazine (DTIC), interleukin-2, and interferon (IFN).

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."

Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body’s immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body’s immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously.

Yervoy’s safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed.

The study was designed to measure overall survival, 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.

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