Bristol-Myers Squibb UFT
Executive Summary
Oral colorectal cancer therapy receives "not approvable" letter from FDA March 23. The NDA for uracil/tegafur for the treatment of advanced colorectal cancer was resubmitted April 20, 2000 after being withdrawn March 17, 2000. FDA's Oncologic Drugs Advisory Committee recommended UFT for approval in September 1999 following analysis of the contribution of uracil. A 1,500-patient cooperative study for the adjuvant treatment of colorectal cancer is expected to complete in 2002