National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
April 5, 2011 • Volume 8 / Number 7

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FDA Update

FDA Approves New Treatment for Late-Stage Melanoma

On March 25, the Food and Drug Administration (FDA) approved ipilimumab (Yervoy) to treat patients with metastatic melanoma. The approval follows a 676-patient trial, which found that patients taking the drug had a median overall survival of 4 months longer than those who had received an experimental therapeutic vaccine.

Ipilimumab is an antibody that works by binding to a molecule on the surface of T cells called CTLA4. This removes a brake that prevents immune cells from attacking the body’s own tissues and cells in melanoma tumors.

Adverse events and side effects are possible when the immune system is stimulated, and ipilimumab can cause complications such as rashes, colitis (inflammation of the colon), and even death. But most adverse events are treatable.

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” said Dr. Richard Pazdur, director of the FDA’s Office of Oncology Drug Products. “[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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