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FDA Approves Innovative Melanoma Drug and Companion Test

Thanks to the FDA’s implementation of several new processes that will accelerate the availability of new medicines on the market, they were able to approve Zelboraf (vemurafenib) and it‘s companion diagnostic test for the treatment of late stage Melanoma on August 17, 2011, two months ahead of the original accelerated approval date of October 28th. Melanoma is a type of skin cancer that occurs when malignant cells develop in melanocytes, the cells that produce your body’s pigmentation. Each year, about 120,000 new cases of melanoma are diagnosed in the US. While melanoma is not the most common form of skin cancer, it is the deadliest killing about 8,700 people annually, which is the equivalent to about one person per hour.  About 50% of people that have metastatic melanoma have a v600E-mutated BRAF protein that is normally involved with regulating cell growth. Zelboraf inhibits the functioning of this mutated protein. Zelboraf’s one-of-a-kind companion, the cobas 4800 BRAF V600 mutation test, will be used to identify this particular mutation in melanoma cells. Unfortunately, the body becomes resistant to the medicine, so it only prolongs one’s life by a few months. Further research is needed, however, it is a huge step in the right direction, not only for fighting cancer, but developing other drugs that offer gene based personalized medicine.

Always keep in mind the A-B-C-D-E’s of early skin cancer detection

    Normal      Melanoma

What to look for:

A-Asymmetry (both halves of the mole should be mirror images of one another)
  B-Borders (edges that are ragged, irregular, or blurry)
  C-color (moles should be one color; melanoma moles are typically more than one color or shade of a color)
  D-Diameter (a mole should be no bigger than the head of an eraser)
E-Evolving (if a mole changes in any way, that can be suspect; moles should not bleed, crust, or itch)

 

To learn more about melanoma visit The National Cancer Institute, or how to prevent and detect skin cancer, download this PDF from the American Cancer Society.

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