FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-21                        Susan M. Cruzan:     301-827-6242
April 30, 1998                
                              Consumer Inquiries:  800-532-4440

FDA APPROVES XELODA FOR BREAST CANCER

FDA has approved Xeloda, a new oral treatment for advanced breast cancer patients, whose tumors are resistant to Taxol (paclitaxel) with an anthracycline, such as Adriamycin (doxorubicin), or in patients whose tumors are resistant to paclitaxel and further anthracycline therapy may be contraindicated. The following may be used to respond to questions.

The approval of Xeloda gives women who are living with advanced breast cancer in the United States another option for treatment of their disease. The new oral formulation, approved for patients with hard-to-treat tumors, is converted by the body to 5-fluorouracil (5FU), a cancer drug which has been given intravenously for many years to treat various types of cancer.

Xeloda has been granted accelerated approval -- a regulatory mechanism that allows early approval of a product for the treatment of life-threatening conditions for which no acceptable alternative treatments exist or which provides a meaningful therapeutic benefit over existing treatments. Accelerated approval is based on a surrogate marker for clinical benefit such as measurable shrinkage of a tumor rather than a documented effect on the clinical benefit itself such as survival.

Xeloda's approval was based on a phase II study showing that some patients demonstrated shrinkage of their tumor while taking the drug. In a subgroup of 43 patients resistant to both an anthracycline and Taxol, about a quarter had shrinkage of their tumor for a median duration of 154 days. In all 135 patients with measurable disease and who had been treated with one cancer drug, Taxol, tumors shrank by at least half in about 18.5 percent of patients.

The most frequently reported side effects in the clinical trial included diarrhea, nausea, vomiting, a painful inflammation of the mouth, fatigue, hand-foot syndrome characterized by a painful rash and swelling of the hands or feet and mild bone marrow suppression. About one third of the patients have serious side effects, but these side effects were generally reversible after interruption of treatment or decreasing the dose.

As a condition of approval, FDA is requiring the manufacturer Hoffmann-La Roche Inc., Newark, NJ to conduct further studies to evaluate clinical benefit. This arrangement corresponds to a March 19, l998 recommendation made by FDA's Oncologic Drug Advisory Committee.

####

[FDA HOME PAGE]