FDA approves new treatment for metastatic melanoma

On friday, the FDA approved a new drug, called Yervoy, that should help some people with very advanced cases of melanoma. The drug works in an interesting way – by revving up the body’s own immune system to fight the melanoma tumors. When melanomas are detected early – as a mole “gone bad” – they can be treated with surgery. But once the cancer has spread (metastasized), treatment of metastatic melanoma has been very difficult. According to the American Cancer Society, there were about 8700 deaths from melanoma in the U.S. last year.

“This is really the first time in the melanoma field that there is a drug that extended survival in a meaningful way,” said Dr. Gerald P. Linette, an assistant professor of medicine at Washington University in St. Louis, who participated in a clinical trial of the drug.

In a randomized study, melanoma patients that had such advanced disease that they had stopped responding to standard treatments that were treated with Yervoy lived about 10 months, compared with 6.4 months for patients in a control group, who received a placebo treatment. Interestingly, more than 20 percent of the people who received Yervoy in the trial lived at least two years, and some of them much longer. So far, there’s no way to predict who will get the long-term response.

Yervoy works by essentially disabling a “brake” on the surface of the body’s T-cells, known as CTLA-4, and could possibly also work for other tumor types, although this has not yet been proven. The drawback is that loosening the restraints on the immune system can lead to dangerous side effects, such as colitis, hepatitis, endocrine dysfunction and skin problems. The F.D.A. said that 12.9 percent of patients treated with Yervoy suffered severe or fatal autoimmune reactions. It’s also crazy expensive, at $120,000 for a 4 dose infusion, given over three months.

More information about melanoma here (NCI link)

Source: New York Times (link)

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