Home » Drug Information » Recently Approved Drugs » 1998
Medical Areas: Endocrinology | Obstetrics/Gynecology | Oncology
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Roche
Approval Status: Approved April 1998
Treatment Area: breast cancer
Xeloda has been granted approval under the FDA's accelerated
approval program.
The approval of the Xeloda pill was based on a study involving
43 patients whose cancer no longer responded to conventional
treatment. In that group, Xeloda appeared to help shrink tumors in
25% of patients.
In a larger study of 162 patients whose cancer was resistant to
normal treatment, Roche reported that tumors shrank by half in
almost 20%.
Side effects including diarrhea, nausea, and fatigue were
manageable and reversible after discontinuation.
