Melanoma Drug Approved by the FDA

Merely Me Health Guide
  • Last summer we reported how a drug called ipilimumab  gave skin cancer researchers hope that there was something doctors could do for patients suffering from advanced melanoma. The original study, published in the August 2010 issue of The New England Journal of Medicine, showed that advanced melanoma patients who received ipilimumab and a peptide vaccine had a median survival of 10 months as compared with 6.4 months for patients who only received the vaccine. To put it another way, this drug can prolong the life of patients suffering from advanced melanoma by as much as 34 percent.

     

    This weekend the New York Times has reported that ipilimumab has recently gained approval from the Food and Drug Administration (FDA). Yervoy (ipilimumab) was developed by Bristol-Myers Squibb and is reportedly one of the first FDA-approved drugs to treat patients who have Metastatic Melanoma. Metastatic Melanoma is melanoma which has spread to other parts of the body.

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    If caught in the early stages, melanoma can usually be successfully cured through surgical incision. Organizations like The American Academy of Dermatology and the American Melanoma Foundation  provide on-going education to help patients recognize the early signs of melanoma.

    Despite skin cancer awareness and prevention programs people still do die from melanoma skin cancer. Although melanoma only accounts for only three percent of all skin cancer cases, it is the cause of more than 75% or skin cancer deaths. One alarming statistic from The Skin Cancer Foundation  is that one person dies of melanoma almost every hour.

     

    There have been few, if any drugs, to make it through clinical trials to offer any significant help for those patients with an advanced stage of melanoma. Although some are hopeful about the FDA approval of Yervoy, there are some disadvantages of using this drug treatment. One disadvantage may be the cost. According to the New York Times article it would cost a patient $120,000 for a complete course of treatment including four infusions given during a three-month period. Financial support through Bristol-Myers Squibb is said to be available for some patients who qualify. More information about their patient assistance program can be obtained by calling 1-800-861-0048.

     

    Patients may also be wary of the potential for severe side effects in using Yervoy, some of which could be fatal. This drug doesn’t attack tumors directly, but instead, enables the immune system to become powerful enough to fight the cancer effectively. Altering the functioning of the immune system can have dangerous repercussions. The Bristol-Myers Squibb website provides a warning to patients about potentially fatal adverse effects: “YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation.” Some of these adverse effects can include things like colitis, hepatitis, dermatitis, neuropathy, and endocrine dysfunction. Patients who take Yervoy would have to be under the careful watch of doctors to look for any signs of these side effects developing.

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    Each patient would have to decide with his or her doctor whether or not the benefits outweigh the risks in using this drug. On average, ipilimumab, was found to extend the life of patients having advanced melanoma by several months. Yet the original study revealed that more than 20% of study subjects who received Yervoy lived for two years or more. Currently there is no way to predict which patients will benefit the most from using this drug.

     

    Clearly this drug is a medical breakthrough and gives hope to medical practitioners and melanoma patients. Yet there still is much research which needs to be done to improve the odds of survival for those who have this type of deadly skin cancer.

     

    For more information about melanoma please refer to the following SkinCancerConnection articles and resources:

     

    Skin Cancer Resources

     

    Introduction to Melanoma

    Treatment for Melanoma

Published On: March 28, 2011