Roche has won approval in Europe for a new use for Xeloda (capecitabine), its fast growing cancer drug that brought in sales of 534 million Swiss francs in 2004 [[02/02/05a]].
Xeloda has been approved by the European authorities for use in place of the standard chemotherapy for colon cancer, intravenous 5-fluorouracil and leucovorin, which is given to kill any cancer cells left after surgical removal of the tumour [[25/08/04e]]. The approval was based on the results of the X-ACT trial, presented at last year’s American Society of Clinical Oncology meeting, which showed that Xeloda was better tolerated than 5-FU/LV and reduced the risk that the cancer would recur by around 14%.
In addition, because Xeloda is orally bioavailable and better tolerated, patients recovering from the surgery can receive some part of their treatment at home rather than in hospital, which could reduce the overall cost of therapy.
The new approval should expand use of Xeloda and provide another boost to Roche’s European oncology franchise, which was bolstered by the launch of another colorectal cancer treatment, Avastin (bevacizumab), in its first EU markets last month [[11/03/05d]].
Xeloda was cleared as a first-line monotherapy for the treatment of advanced metastatic colorectal cancer in the European Union and the USA in 2001 [[02/05/01d]]. The agent is also approved as a monotherapy after failure of intensive chemotherapy in colorectal cancer, as well as in combination with Sanofi-Aventis’ Taxotere (docetaxel) after failure of anthracycline-containing therapy in metastatic breast cancer.