FDA News

Roche Submits Application to the FDA for use of XELOX (Xeloda) plus oxaliplatin) With or Without Avastin for the Treatment of Advanced Colorectal Cancer

(March 26, 2007)--Roche announced the submission of a supplemental new drug application (sNDA) to the U.S. 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 Lars Birgerson, Vice President, Medical Affairs, Roche.

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, FOLFOX-4 (intravenous bolus and infusional 5-fluorouracil plus oxaliplatin). Study NO16966 also showed that XELOX in combination with Avastin further improved progression-free survival over XELOX alone.

"By showing XELOX to be as effective as FOLFOX in both the first and second line settings, these studies not only demonstrate its promise as a new combination therapy for patients with advanced colorectal cancer, but also support a potential alternative to intravenous chemotherapy with oral Xeloda," said Ed Chu, Professor of Medicine and Pharmacology, Deputy Director of the Yale Cancer Center. "In these trials the data also show that adding Avastin to XELOX further improved progression-free survival, making XELOX plus Avastin a very important and effective treatment option."

Colorectal cancer is the third most common cancer in the U.S. The American Cancer Society estimated that in 2006, more than 148,000 people were diagnosed with the disease and about 55,000 people died from it.

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