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FDA Approves Drug Found to Prolong Lives of Melanoma Patients

March 25, 2011 -- PCF’s Take: Today’s FDA approval of ipilimumab for the treatment of malignant melanoma is the second immunotherapy approved for the treatment of cancer. This represents an important step forward for the field of immunotherapy—signaling the body’s immune system to attack cancer cells. Provenge, used to treat patients with advanced metastatic prostate cancer, was the first immunotherapy approved for patients in April 2010.

Ipilimumab was developed with both melanoma and prostate cancer patients in mind. It is a monoclonal antibody that “takes the brakes off” the immune response and enhances a patient’s immunological attack against a tumor. Ipilimumab is the first agent shown to cause tumor regression in prostate cancer patients and is currently being evaluated in Phase III clinical trials in patients with metastatic prostate cancer. Researchers hope that the drug may be available for these patients within a few years.

James Allison, MD, a PCF-supported research at Memorial Sloan-Kettering in New York, has dedicated a large amount of his research to investigating the clinical action of ipilimumab. “With immunotherapy, we are really treating the immune system, not the tumor. This drug has shown to prolong survival in 20-25 percent of melanoma patients when given in combination with other treatments such as palliative radiation,” says Allison. “We are now looking to determine how ipilimumab, in combination with other therapies, can best serve prostate cancer patients.”

PCF first invested in immunotherapy research in the 1990s when, according to traditional medical thinking, the concept was considered impossible, if not heretical. To date, PCF has invested more than $18 million in research that has supported the development of immunotherapy. Our Prostate Cancer Clinical Trials Consortium (PCCTC), funded jointly with the U.S. Department of Defense, has provided crucial support in enrolling patients for trials and moving innovative therapies, including ipilimumab and Provenge, from microscope to bedside more rapidly.

Read the New York Times article about the FDA's approval of ipilimumab for the treatment of malignant melanoma

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