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FDA Approves New Melanoma Drug

By HERWriter
 
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Metastatic Melanoma related image Photo: Getty Images

On March 25, 2011, the United States Food and Drug Administration approved a new drug called Yervoy (ipilimumab) to be used to treat late-stage melanoma. Melanoma is the most dangerous form of skin cancer. Yervoy, developed by Bristol-Myers Squibb, is the first drug that has been shown to prolong life in these melanoma patients demonstrated in an international study of 676 patients.

What is melanoma?

Melanoma is a form of skin cancer that develops in the melanocytes, the cells in the skin that produce pigment. “An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease," according to the National Cancer Institute.

Melanoma may start in a mole, which can be removed, but once the melanoma has spread throughout the body it is much more difficult to treat. Currently there are drugs on the market to treat melanoma but none have shown the improved survival rate that Yervoy has.

“The randomized clinical trial (testing Yervoy) showed that people receiving the drug lived a median of 10 months, compared to 6.4 months for patients in a control group, who receive a treatment believed to have little effect,” according to the New York Times article printed March 27, 2011.

Yervoy is not like other typical chemotherapy drugs that act by killing off cancerous cells. Instead, Yervoy acts by boosting the immune system to fight tumors. Yervoy works by blocking a protein called CTLA-4 (cytotoxic T-lymphocyte antigen 4) on the surface of T cells, the immune system’s main fighters. This essentially blocks the limiting controls on those cells allowing them to work harder. A similar type of drug was released last year called Provenge to treat prostate cancer.

The drawback of taking Yervoy is that it can cause some serious side effects such as colitis, hepatitis, endocrine or skin problems. According to the FDA report in the New York Times, “12.9 of patients treated with Yervoy suffered severe or fatal autoimmune reactions.”

In addition, Yervoy may take weeks to enable the immune system to ramp up so it is not a good choice of drug for those with aggressive melanoma. Those patients do not have the time to wait. Use of more traditional chemotherapy drugs that kill tumor cells would be selected instead.

Roche and Plexxikon are also working on a similar drug that prolongs the lives of those with metastatic melanoma. They currently are involved in clinical trials. Overall, these types of drug may be the future of treatments for a variety of types of cancer.

sources:
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm
www.nytimes.com/2011/03/26/business/26drug.html?hpw

Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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