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The US Food and Drug Administration (FDA) announced today the approval of ipilimumab (Yervoy, Bristol-Myers Squibb) for the treatment of advanced melanoma as a second-line therapy.

Ipilimumab is the first agent ever proven to improve survival in advanced melanoma. Its Biologics License Application was granted priority review designation in August 2010.

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 8700 people died from the disease, according to the National Cancer Institute.

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

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