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FDA approves new drug for advanced melanoma
Date:3/25/2011

BOSTON--The U.S. Food and Drug Administration today approved the use of ipilimumab for the treatment of previously treated metastatic melanoma. It is the first drug approved for metastatic, or advanced, melanoma is more than a decade.

"Ipilimumab is the first in a new class of drugs that has been shown to offer a survival benefit for metastatic melanoma, which is often a fatal disease, and hopefully, this will lead to the development of related treatments for other cancers," said F. Stephen Hodi, MD, director of the melanoma treatment center at Dana-Farber Cancer Institute and a lead investigator of the national clinical study of ipilimumab.

The number of cases of metastatic melanoma, considered to be one the most serious form of skin cancer, has increased during the past 30 years, and its death rate is rising faster than most other cancers. The American Cancer Society estimated that the disease was diagnosed in more than 68,000 Americans and be responsible for 8,700 deaths in this country in 2010.

Ipilimumab, developed by Bristol-Myers Squibb and Medarex, is a monoclonal antibody that consists of millions of copies of a human antibody that binds to CTLA-4 protein molecule on T cells white blood cells that patrol the body for signs of illness. CTLA-4 serves as a control switch for the immune system's response to disease. With no antibody attached, CTLA-4 suppresses the immune response. Ipilimumab reverses that condition, unleashing the immune attack on abnormal cells, including cancer cells.

Last year, Hodi reported at the annual meeting of the American Society of Clinical Oncology and in the New England Journal of Medicine findings from a phase III trial involving 676 patients with advanced (stage III or IV), inoperable melanoma that had worsened during prior therapy for metastatic disease.

Patients were randomly assigned to receive one of three treatment regimens: ipilimumab and the gp100 vaccine (which seeks t
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Contact: Bill Schaller
william_schaller@dfci.harvard.edu
617-632-5357
Dana-Farber Cancer Institute
Source:Eurekalert  

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FDA approves new drug for advanced melanoma
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