Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved May 2001
Treatment Area: Oncology
Xeloda has been approved for use as a first-line treatment for
subjects with metastatic colorectal cancer when treatment with
fluoropyrimidine therapy alone is preferred. Xeloda is available in
tablet formulation, which provides significantly more convenience
in dosing compared to other more complex intravenous chemotherapy
With approximately 130,000 new cases reported each year,
colorectal cancer is the third most common cancer in the United
States. About 20% of subjects have metastatic disease when first
diagnosed and 50% will develop metastases and ultimately die from
the disease. The five year survival rate for those with advanced
metastatic disease is less than 10%. An estimated 56,300 people
will die from colorectal cancer in 2001.
The FDA's approval of Xeloda was based on results from two
multi-national phase III trials involving 1,200 subjects with
metastatic colorectal cancer. Results showed that Xeloda shrank
tumors more effectively than a standard care of intravenous
fluorouracil and leucovorin, known as the Mayo Regimen. One trial
reported overall response rates to Xeloda as being more than double
those to the Mayo Regimen, while in the other, the response to
Xeloda was 30% greater than that to the intravenous therapy.
Adverse events associated with the use of capecitabine may
include (but are not limited to) the following:
- Hand-and-foot syndrome
Mechanism of Action
Xeloda is the first oral drug that works through enzymatic
activation of the cancer fighting substance fluorouracil (5-FU).
Once in the body, Xeloda is converted into 5-FU by the naturally
produced enzyme thymidine phosphorylase (TP).
For additional information on Xeloda, please visit