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20 June, 2005: US Food and Drug Administration (FDA) has approved Roche's Xeloda (capecitabine), an oral chemotherapy drug for adjuvant (post-surgery) treatment of colon cancer patients. Adjuvant chemotherapy is the standard treatment approach for Dukes’ C colon cancer (Stage III cancer that has spread to the lymph nodes).
The nod helps patients who have undergone complete resection of their primary tumour the option of an oral chemotherapy when treatment with fluoropyrimidine therapy alone is preferred.
Xeloda as an oral fluoropyrimidine compares favourably with intravenous infusion requiring multiple hospital visits, the company said in a statement. Xeloda drug had received European approval in March 2005.
Said William M Burns, chief executive officer Roche Pharma: “Now, colon cancer patients will have access to a unique treatment option that provides an effective oral therapy which is well-tolerated and can be taken at home.”
The FDA’s decision was based on Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) trial. The trial successfully met its primary endpoint, showing Xeloda is non-inferior to 5-FU/LV for disease-free survival.
On average, a patient only needed eight hospital visits when treated with Xeloda compared to 30 visits if treated with IV 5-FU/LV2. This results in significant cost savings, an important advantage for doctors, nurses and pharmacists in today’s healthcare environment.
Roche has a large ongoing study programme looking at Xeloda in combination with other chemotherapies and targeted therapies in breast and colon cancer.
BY OUR PHARMA CORRESPONDENT
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