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FDA Approves Novel Melanoma Drug
Date:8/17/2011

WEDNESDAY, Aug. 17 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday gave its approval to Zelboraf (vemurafenib), a first-of-its-kind drug for the treatment of an often lethal form of melanoma.

The drug targets a gene mutation that's present in about half of melanomas, the deadliest form of skin cancer.

"Zelboraf is a huge step forward in the fight against metastatic melanoma and the advancement of treatment for the deadliest form of skin cancer," Dr. Anna Pavlick, director of the NYU Melanoma Program at the NYU Cancer Institute, New York City, said in a university statement. She took part in phase II and III trials of the drug and is an advisor to Zelboraf's maker, Genentech.

"The approval of Zelboraf will make a significant impact on the survival and outcomes of advanced melanoma patients," Pavlick added. "Patients taking the drug Zelboraf were 63 percent less likely to die from advanced melanoma than patients given standard chemotherapy alone," she noted.

Another expert agreed that Zelboraf may be a potent weapon against melanoma for some patients.

The drug's approval "represents a breakthrough accomplishment in targeting a therapy to a specific group of patients who can benefit," Wendy K.D. Selig, president and chief executive officer of the Washington, D.C.-based Melanoma Research Alliance, said in a statement.

The FDA approval is specifically for patients with melanoma tumors that express a gene mutation called BRAF V600E.

BRAF typically helps regulate cell growth, but the variant of BRAF targeted by Zelboraf "is the abnormal gene mutation that allows melanoma cancer cells to spread," Pavlick explained. "Since almost 50 percent of all melanoma tumors have the BRAF genetic mutation, this targeted drug therapy can be of great benefit to many patients."

Along with the drug, the FDA also approved a companion test (made by Roche Molecular Systems) that will help
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