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Novel immunotherapy drug receives FDA approval for the treatment of metastatic melanoma
Date:3/25/2011

New York, March 25, 2011 The US Food and Drug Administration announced today that the drug ipilimumab (brand name Yervoy) has been approved for the treatment of patients with metastatic melanoma. It is the first drug ever shown to improve overall survival for patients with advanced melanoma.

Ipilimumab uses a novel approach known as immunotherapy, which exploits the body's own immune system to attack cancer. The therapy, originally known as anti-CTLA-4, was developed in 1996 by James Allison, PhD, Chair of the Sloan-Kettering Institute's Immunology Program at MSKCC. For more than 20 years, Dr. Allison's research has focused on the mechanisms that regulate the immunologic responses of T lymphocytes commonly referred to as T cells with an emphasis on manipulating T cell response in order to develop novel tumor immunotherapy approaches.

Over the years, Memorial Sloan-Kettering researchers were deeply involved in preclinical and clinical studies using ipilimumab, most notably a 2009 phase II multicenter trial led by medical oncologist Jedd Wolchok, MD, PhD. Dr. Wolchok was a participant in the phase III trial, presented in 2010 at the American Society of Clinical Oncology annual meeting, which found a dose-response relationship to the drug in patients with stage III or IV disease. He also led a team in the development of a novel set of tumor-response criteria based on ipilimumab's unique mechanism of action.

Together, recent advances in understanding intracellular signaling pathways and immunotherapies such as ipilimumab to block those pathways have allowed clinicians to offer melanoma patients new treatment options for this disease.

"Ipilimumab is the first drug ever to be shown to produce an improvement in overall survival for patients with metastatic melanoma," according to Dr. Wolchok. "This is a significant achievement in a disease which has been so resistant to standard therapies. It is also a great source of hope for
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Contact: Jeanne DAgostino
dagostij@mskcc.org
212-639-3573
Memorial Sloan-Kettering Cancer Center
Source:Eurekalert

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