According to the anniouncement made in Washington, the drug named Zelboraf, was approved for patients with metastatic melanoma, the most life-threatening form of skin cancer and one form that cannot be removed with surgery.
According to scientists, the drug is the latest in a new generation of cancer-fighting drugs specifically medically tailored to attack genetic vulnerabilities of malignancies. The FDA explained that Zelboraf was approved only for tumors with a specific genetic mutation. The drug was approved with a test that can determine if a patient’s cancer has this particular mutation.
The research testing and findings found that the mutation which produces a version of a protein that is normally involved in regulating cell growth is mutated in about half of patients with advanced melanoma. The report concluded that Zelboraf inhibits the activity of the mutated protein.
Zelboraf, which is marketed by Genentech of San Francisco. The medication was reviewed under the FDA’s priority review program, which enables the agency to approve drugs quickly.
In a study involving 675 patients with late-stage melanoma with the mutation, 77 percent of those who received Zelboraf were still living, while only 64 percent of those who received a standard chemotherapy drug known as dacarbazine survived eight months, the FDA said.
Melanoma is the leading cause of death from skin disease. About 68,130 new cases of melanoma are diagnosed and about 8,700 people die from the disease each year in the United States according to Jesse Slome, executive director of the American Association for Critical Illness Insurance http://www.criticalillnessinsuranceinfo.org which tracks health news related to cancer and heart disease.
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