Xeloda
Company: Roche
Approval Status: Approved May 2001
Treatment for: Oncology
Areas: Oncology
Possible similar drugs: Xeloda
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
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 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.
Clinical Results
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.
Side Effects
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
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).
Additional Information
For additional information on Xeloda, please visit Xeloda.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
