Melanoma is the most deadly type of skin cancer. The National Cancer Institute estimated that 68,130 new cases of melanoma were diagnosed last year in the United States. This week the FDA approved Zelboraf, a new pill for the treatment of late-stage, irremovable melanoma. The prescription drug works by targeting a gene mutation that appears in about half of melanomas.
The new drug will not be helpful to all patients. According to the FDA, Zelboraf is intended for patients with melanoma whose tumors have a specific gene mutation called BRAF V600E. In addition to the actual drug, the FDA has also approved a test that will help determine if a patient’s melanoma cells have this certain mutation. Usually, the BRAF protein helps regulate cell growth, but it is muted in nearly half the patients with late-stage melanomas. Zelboraf is a BRAF inhibitor which has the ability to block the function of the V600E-mutated BRAF protein, says the FDA.
“This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” says Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “In March, we approved Yervoy, another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug.”
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