Providence cancer drug trial wins FDA approval

April 11, 2011

An international study led by a team from Providence Cancer Center has resulted in approval by the Food and Drug Administration of a new drug. Ipilimumab is the first drug shown to extend survival in patients with late-stage melanoma.

The trials that led to the drug’s approval began in 2004 and took place at 125 centers in 13 countries. The study’s principal investigator was Walter J. Urba, M.D., Ph.D., director of cancer research at the Robert W. Franz Cancer Research Center in the Earle A. Chiles Research Institute at Providence Cancer Center. Results of the study were published last year in the New England Journal of Medicine.

The drug is a form of immunotherapy that works by a different mechanism than other cancer drugs. It is a human monoclonal antibody that activates a patient’s own immune T cells to kill cancer cells.

In clinical trials, the drug appeared to double survival. After two years, 24 percent of patients treated with ipilimumab were alive, while survival dropped to 14 percent among patients given a standard treatment. Providence Cancer Center was the only site in Oregon that provided the drug to patients under “compassionate use” rules set by the FDA. The drug now will become more widely available.

Melanoma is a particularly deadly form of skin cancer that results in more than 60,000 new U.S. cases every year and about 8,500 deaths. Cases that are found early can be cured with surgery, but most patients who are diagnosed after melanoma has spread to other organs die within a year.

“This is the first new drug for melanoma in 13 years, and it will make a big difference for patients who until now faced limited treatment options,” says Dr. Urba. He believes ipilimumab also will be effective against other cancers, and Providence Cancer Center currently is testing the drug’s effectiveness against prostate cancer.