Roche Xeloda Confirmatory Trial May Require Design Changes, FDA Indicates
Executive Summary
Roche's Phase III trial to confirm the clinical efficacy of Xeloda in treatment of breast cancer may require amendments or an alternative trial, FDA has suggested to the company. Xeloda (capecitabine) received accelerated approval April 30 on the basis of a Phase II trial that measured tumor response rates in patients resistant to previous therapy.