Promising Advances in Melanoma Treatment

Study prompts FDA to 'fast track' new drug for late-stage patients

(RxWiki News) Ipilimumab, a new medicine developed to combat metastatic melanoma, has been shown to improve survival rates in stage IV of the disease.  A new study from the John Theurer Cancer Center at Hackensack University Medical Center, published in the New England Journal of Medicine, has prompted the Food & Drug Administration (FDA) to fast-track its analysis of the drug. The pill, tested in randomized, placebo-controlled trials, is the first of its kind to improve survival in metastatic melanoma patients.


Andrew L. Pecora, M.D., F.A.C.P., C.P.E., chairman and executive administrative director at the John Theurer Cancer Center, led the study, which he said provides “new hope for people with this devastating cancer.”

Death rates for those diagnosed with melanoma have risen faster than most other cancers in recent years. Approximately 68,000 new cases of melanoma were diagnosed in 2009 amid 8,700 deaths from the disease, according to the American Cancer Society.

The cancer, which is difficult to treat once it has spread beyond the skin to other parts of the body, accounts for about 80 percent of all skin cancer-related deaths. 

To participate in the phase III study, the 676 participants had to have been diagnosed with stage III or IV (metastatic) melanoma, and not responded to other cancer drugs. Each had to have at least a four-month life expectancy.  Those who received ipilimumab lived a median 10 months, approximately, while those who were given the placebo (known as gp 100) lived only about 6.4 months.

About 23 percent of patients who received the drug were still alive after two years, while only 14 percent of those who did not take the pill remained alive.  

The FDA grants priority status to drugs that offer major treatment advances. The Administration has proposed an action date of Dec. 25 regarding its ruling on the new drug.

The advance arrives on the heels of other encouraging news in the treatment of melanoma. A new drug known as PLX4032 has proven effective at shrinking advanced tumors in 81 percent of patients in a recent clinical trial. The drug almost completely blocks a chemical pathway in the tumor cells to reduce the size of tumors, according to Gideon Bollag of the California-based biotechnology company Plexxikon, who led the study.

Plexxikon President Kathleen Galub called attention to recent developments in cancer medicine: "I think all of us in this industry have to figure out different ways to develop drugs that are more efficient and enable us to move development faster," she said.

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September 14, 2010