EU approval for Roche's Xeloda in CRC

The European Commission has granted marketing approval for Roche'sXeloda (capecitabine) for the treatment of metastatic colorectal cancer. The company notes that this is the first oral chemotherapy approved in the European Union for this condition, and offers patients superior response rates, as well as improved safety and convenience.

Xeloda is already approved for metastatic CRC in Canada, Australia and Switzerland, among other countries, and last year it received an approvable letter from the US regulatory authorities (Marketletter October 2, 2000). Since 1998, it has also been cleared for the treatment of metastatic breast cancer, and analysts have suggested a peak sales target for Xeloda of $200-$300 million a year.

Clinical studies show benefits