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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.0650+0.2%12:36 PM EST
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From: boomertree25/30/2013 8:25:49 AM
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FDA Approves Two Advanced Melanoma Treatments, Genetic Test. The Wall Street Journal (5/30, Jones, Subscription Publication) reports that the US Food and Drug Administration on Wednesday announced it has approved two oral treatments for metastatic or unresectable melanoma – Tafinlar (dabrafenib) and Mekinist (trametinib) – both of which are marketed by GlaxoSmithKline.

Reuters (5/30, Berkrot) notes that the FDA stipulated that the two newly approved drugs were approved as single agents and should not be administered in combination with other therapies. Additionally, in the same statement, the agency announced that it has approved a companion diagnostic that detects V600E or V600K mutations in the BRAF gene. Tafinlar is a BRAF inhibitor whereas Mekinist is an MEK inhibitor. Grenoble, France-based bioMérieux manufactures the diagnostic test, which is called THxID BRAF Kit.

The Los Angeles Times (5/30, Healy) “Science Now” blog adds that the reason the agency barred the pairing of treatments is because “early trials” combining similar drugs – Yervoy (ipilimumab) with Zelboraf (vemurafinab) – “suggested the combination is toxic to the liver.” Moreover, findings from clinical trials testing the newly approved drugs “suggested that patients who got Tafinlar or another BRAF inhibitor first did not benefit from Mekinist.” The FDA approved Bristol-Myers Squibb’s Yervoy and Genentech’s Zelboraf to treat “advanced and/or inoperable” melanoma in 2011.
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