Reuters: Regulatory News: UPDATE 1-GSK cancer drug combination wins US priority review

Reuters: Regulatory News Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

The Best Way to Manage your Money. Start using Mint today to set a budget, track your goals and do more with your money. From our sponsors

UPDATE 1-GSK cancer drug combination wins US priority review Sep 16th 2013, 10:07 Mon Sep 16, 2013 6:07am EDT LONDON, Sept 16 (Reuters) - A combination treatment from GlaxoSmithkline for melanoma, the deadliest form of skin cancer, has won priority review from U.S. regulators. The move means the Food and Drug Administration will now decide whether to approve the dual use of Tafinlar, also known as dabrafenib, and Mekinist, or trametinib, by early January. Both drugs are already approved for separate use but GSK believes they will have a longer-lasting effect if given together. Industry analysts also see a combination offering the greatest commercial potential. Tafinlar, which is similar to Roche's rival medicine Zelboraf, is designed to work in patients with a mutation of a gene known as BRAF. So-called BRAF inhibitors have been remarkably effective in shrinking melanoma tumours but most patients eventually develop resistance to the drugs. By combining Tafinlar with Mekinist, which works in a different way, the hope is that the cancer will be held at bay for longer. GSK said on Monday that the FDA had set a target date of Jan. 8, 2014 for the review of the Mekinist supplement and Jan. 9 for the Tafinlar supplement. If approved, the drug combination will be used to treat melanoma that cannot be removed by surgery or which has spread to other organs. The applications are based on data from a randomised study comparing combination therapy to Tafinlar given alone. Melanoma is diagnosed in nearly 160,000 people worldwide each year. It can spread quickly to internal organs and average survival is six to nine months. Link this Share this Digg this Email Reprints

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions