Roche Xeloda launch press release
Executive Summary
Company implied "greater efficacy for Xeloda than has been demonstrated, given the basis for approval, that is, effects on surrogate markers," FDA told the company in a June 8 letter. Xeloda received accelerated approval for treatment of breast cancer April 30 ("The Pink Sheet" May 4, p. 3). FDA specifically objected to the statements "We anticipate that Xeloda will help redefine chemotherapy" and "At last, patients can take an effective pill, in their homes, to treat their cancer." The latter statement "is also false and misleading because it implies that there are no other oral chemotherapy agents for the treatment of advanced breast cancer," FDA said. FDA also objected to the failure of the press release to include the full wording of the indication and to its summary of side effects as including "minimal hair loss and limited bone marrow depression." Roche said it is in discussions with FDA to resolve the issues raised in the letter
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth