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Zelboraf Approved for Late-Stage Melanoma Thu Aug 18, 2011 6:19 am
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Zelboraf Approved for Late-Stage Melanoma


Aug. 17, 2011 -- The FDA today approved Zelboraf, a drug that can extend survival for the 50% of melanoma patients whose tumors carry the BRAF V600E mutation.

Zelboraf is approved for inoperable or late-stage melanoma that tests positive for the BRAF mutation. In concert with the drug approval, the FDA also approved a new test for the BRAF mutation.

Zelboraf does not cure melanoma, which this year will kill some 9,000 Americans. But Zelboraf will make a big difference in the lives of BRAF-positive melanoma patients, says Anna Pavlick, DO, co-director of the melanoma program at New York University's Cancer Institute. Pavlick was one of the investigators in Zelboraf clinical trials.

"We now have the capacity to analyze a patient's melanoma tumor for the genetic mutation BRAF and use the targeted treatment Zelboraf to attack the tumor, shrink it, and stop the progression of this deadly disease," Pavlick says in an NYU news release. "The drug comes in a simple pill form, taken twice a day, and has been well tolerated by patients."

Nevertheless, Zelboraf has some serious side effects. Some 26% of patients in clinical trials developed a nonmelanoma form of skin cancer called cutaneous squamous cell carcinoma, which can usually be removed via relatively simple surgery.

Other side effects include joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity to sunlight. Patients taking Zelboraf must avoid sun exposure.

http://www.webmd.com/melanoma-skin-cancer/news/20110817/zelboraf-approved-for-late-stage-melanoma?src=RSS_PUBLIC
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Zelboraf Approved for Late-Stage Melanoma Thu Aug 18, 2011 6:19 am
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