Reuters: Regulatory News: Data supports fast approval for Roche's breast cancer drug -FDA staff

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

TypePad Has the Tools Looking for a premiere blogging service? Start your blog today on TypePad. From our sponsors

Data supports fast approval for Roche's breast cancer drug -FDA staff Sep 10th 2013, 12:41 Sept 10 | Tue Sep 10, 2013 8:41am EDT Sept 10 (Reuters) - Trial data on Swiss drugmaker Roche's breast cancer treatment Perjata supported a faster approval of the drug for use in early stages of the disease, reviewers for the U.S. Food and Drug Administration said on Tuesday. The FDA review team believed that the totality of the data submitted, including study results and the drug's safety profile, supported an accelerated approval, documents posted on the FDA's website on Tuesday said. () Roche is seeking approval for Perjata as a neoadjuvant, or initial, treatment for early stage breast cancer patients whose cancer cells contain increased amounts of the HER2 protein. A neoadjuvant treatment is given in the beginning to shrink a tumor before the main treatment. If approved, Perjeta, to be used in combination with Roche's older breast cancer drug Herceptin and chemotherapy drug docetaxel, would be the first neoadjuvant breast cancer treatment approved by the FDA.

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