Roche sumission for Xelox in treatment of colorectal cancer

Published: 28-Mar-2007
Regulatory

Roche has submitted 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.


Roche has submitted 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.

The submission to the FDA is based on results from two large, international, Phase III studies (NO16966 and NO16967), which showed Xelox to be as effective - in terms of progression-free survival (PFS) - as the current standard treatment. 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.

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