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article imageFDA approval for first melanoma drug extending patients' lives

By Adeline Yuboco     Mar 26, 2011 in Health
Washington - Drug manufacturer Bristol-Myers Squibb Co. received the U. S. stamp of approval on Friday to manufacture and market the first drug medication to extend the lives of patients suffering from melanoma.
The Food and Drug Administration (FDA) approved the chemical drug ipilimumab, which will be marketed under the name Yervoy, as an injectable medication for the initial treatment for patients diagnosed with advance stages of melanoma—a skin cancer that spreads into the other organs and tissue—by unleashing the body's own immune system to fight off the tumors. Although there has been two other drugs approved by the FDA for the treatment of melanoma, ipilimumab is the first drug proven to extend the live expectancy of patients diagnosed with melanoma.
The approval was based on a study conducted by Bristol-Myers Squibb on 676 patients who have all been diagnosed with inoperable stages of melanoma, and have been given by their respective doctors a very short life expectancy. Based on the findings of the study that they have conducted, patients that were administered with ipilimumab survived an average length of ten months as opposed to those that have been given other forms of medication. In addition, a very small percentage of patients survived longer than six years. A complete discussion and presentation of the study conducted by the said drug manufacturer was published at the August 2010 issue of the New England Journal of Medicine.
While it may have been given an approval from the FDA, the use of Yervoy as a form of treatment against advanced stages of melanoma has a number of side effects that patients may experience during the treatment due to the fact that it treats the patient's immune system, not the tumor directly. 12.9% of the patients that participated in the study were reported to have suffered a variety of reactions after taking the treatment, which ranged from colitis and diarrhea to endocrine dysfunction and skin problems.
Another drawback of the drug is that it may take weeks for the patient's immune system to mount its attack on the melanoma tumors, something that "many people with really aggressive melanoma don't have," Dr. Jeffrey A. Sosman—professor at the Vanderbilt-Ingram Cancer Center located in Nashville.
Still, many medical practitioners are hopeful about the potential of this drug to eventually successfully treat melanoma as Tim Turnham, director of the Melanoma Research Foundation, points out.
"Clearly, this is not a home run," he said, "but it's a solid base hit. And because we see other things in the pipeline, we think this [is] the first in a series of important new therapies for melanoma."
Yervoy will cost $30,000 a dose, or a total of $120,000 for the complete course of the treatment.
More about food and drug administration, Melanoma, Skin cancer, Yervoy, ipilimumab
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