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