Roche's Xeloda cleared as first-line colorectal cancer therapy in USA

Roche's orally-active anticancer drug Xeloda (capecitabine) has beenapproved by the US Food and Drug Administration for the first-line treatment of metastatic colorectal cancer when fluoropyrimidine therapy alone is preferred. The drug was approved and launched for this indication in the European Union earlier this year (Marketletter February 19), and it is already available in most major markets as a therapy for metastatic breast cancer.

Roche has high hopes for Xeloda, which offers an alternative to infusional treatments, such as the Mayo regimen of 5-fluorouracil and leucovorin, which are inconvenient for patients, labor-intensive for medical staff and frequently associated with venous-access-related complications. This positive view is backed up by new data showing that Xeloda is both more efficacious and better tolerated than the Mayo regimen in colorectal cancer (Marketletter April 23), as well as a new report from Frost & Sullivan which suggests that the US market for colorectal cancer therapies will increase from $425 million in 2000 to more than $3 billion in 2007.

At the moment, Pharmacia's Camptosar (irinotecan) is the only branded product approved in the USA as a first-line treatment for colorectal cancer, in combination with 5-FU and leucovorin, and this is emerging as a new standard treatment for the disease. However, as Camptosar is given as an infusion there is clearly scope for Roche to carve out a market for its oral competitor.