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Company: Roche
Approval Status: FDA Approved May 2001
Specific Treatments: Oncology
Drug: Capecitabine



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.

It is available in tablet formulation, which provides significantly more convenience in dosing compared to other more complex intravenous chemotherapy regimens.

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 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:

  • Diarrhea
  • Nausea
  • Vomiting
  • Stomatitis
  • Hand-and-foot syndrome
  • Dermatitis
  • Fatigue



It 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).

Source: centerwatch