Xeloda Approved for Metastatic Colorectal Cancer

NUTLEY, NJ—The FDA has approved Roche’s Xeloda (capecitabine) for the first-line treatment of metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit, compared with intravenous fluorouracil (5-FU)/leucovorin alone, and no survival benefit has been show with Xeloda monotherapy.

Xeloda is an oral drug that is converted to 5-FU via the action of thymidine phosphorylase. It was initially aproved in 1998 for the treatment of patients with resistant metastatic breast cancer.

The FDA decision was based on the results of two multinational phase III clinical trials of 1,200 patients with metastatic colorectal cancer randomized to 5-FU/leucovorin (the Mayo regimen) or Xeloda. In both studies, time to disease progression and survival were similar in both arms. The overall response rate was higher for Xeloda in both studies: 21% vs 11% and 21% vs 14%.