Roche has announced the submission of a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the use of Xeloda (capecitabine) in combination with oxaliplatin - Xelox - with or without Avastin (bevacizumab) in the treatment of metastatic colorectal cancer.
"This filing marks a significant milestone for Xeloda, which continues to demonstrate its value as a cornerstone in combination therapies, as in this case with oxaliplatin and Avastin. It further supports Roche's longstanding commitment to advancing treatment for patients with colorectal cancer," said Jean-Jacques Garaud, Roche's Global Head Pharma Development.
The submission to the FDA is based on results from two large, international, phase III studies which showed Xelox to be as effective - in terms of progression-free survival (PFS) - as the current standard treatment, Folfox- (intravenous bolus and infusional - fluorouracil plus oxaliplatin).
Study NO16966 also showed that Xelox in combination with Avastin significantly improved progression-free survival over Xelox alone.
In Europe, Roche will be applying for a label extension for Xeloda use in combinations, including with oxaliplatin (Xelox) and Avastin, for the treatment of metastatic (advanced) colorectal cancer. Similarly, the label extension for Avastin broadens the use of the treatment to include combination with fluoropyrimidine- based chemotherapy in patients with metastatic cancer of the colon or rectum.
Avastin was first approved, in Europe, in January 2005 for first-line treatment of patients with advanced colorectal cancer in combination with chemotherapy regimens of intravenous