FDA Approves Oral Treatment for Colorectal Cancer

The US Food and Drug Administration has approved the first oral chemotherapy treatment for colorectal cancer that has spread to other parts of the body, the drug's manufacturer announced on Tuesday.

The drug, called Xeloda (capecitabine), reacts in the body with an enzyme that converts the drug into 5-fluororurocil, or 5-FU, a standard therapy for the disease that has been used for many years.

Xeloda, just the second treatment for colorectal cancer approved in the U.S. in the past 40 years, could also offer convenience to patients over current treatments for colorectal cancer because it is taken orally twice a day rather than by intravenous infusions, according to Hoffman-La Roche Inc.

The FDA first approved Xeloda in May 1998 for the treatment of breast cancer that had spread in the body and was resistant to standard therapy.

Roche said Xeloda's approval for metastatic colorectal cancer follows two large Phase III clinical trials that showed it shrank tumors better than a standard intravenous treatment containing the chemotherapy agents fluorouracil (5-FU) and leucovorin, known as the Mayo Regimen.

Other sources: Reuters, FDA