FDA Approves New Drug to Treat Advanced Skin Cancer
It is a break-through in the world of advanced Malenoma, the life-threatening form of skin cancer, with the Food and Drug Administration (FDA) announcing approval of a new drug to treat the disease on Wednesday.
The drug, known as Zelboraf, has been approved for patients with metastatic melanoma which cannot be cured with surgery.
Zelboraf, which was approved only for tumors with a genetic mutation known as BRAF V600E, is the latest in the new generation of "personalized'' cancer-fighting drugs tailored to attack genetic vulnerabilities of malignancies, a boston.com report said.
It was approved with a test that can determine if a patient's cancer has the mutation.
The drug is marketed by Genentech of San Francisco and was reviewed under the FDA's priority review program, which enables the agency to approve drugs quickly.
A study was conducted to see the effect of the drug on patients with advanced melanoma.
Out of the 675 patients who had reached a late-stage of melanoma with the mutation, 77 percent of those given Zelboraf were still living. However, 64 percent patients who received a standard chemotherapy drug known as dacarbazine survived eight months, the FDA said, according to the report.
"Today's approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner,'' said Alberto Gutierrez, director of the FDA's office of in vitro diagnostic device evaluation and safety, in a statement.
A major cause of death from skin disease, Melanoma kills about 8,700 people in the United States alone.
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