Roche announced that the European Commission (EC) has given its approval for the significantly wider use of its anti-angiogenic agent Avastin (bevacizumab) in patients suffering from metastatic colorectal cancer.

This new broader label will now allow Avastin to be used in combination with any chemotherapy, including Roche's oral chemotherapy Xeloda (capecitabine), for 1st and later treatment lines in patients with metastatic colorectal cancer. This news means that virtually all patients with metastatic colorectal cancer now have access to Avastin's proven survival benefits. It is estimated that more than 400,000 people in Europe will be diagnosed with metastatic colorectal cancer in 2008.

The Avastin approval follows the European Committee for Medicinal Products for Human Use (CHMP) positive recommendations for the extended use of both Avastin and Xeloda in December 2007. The final EC decision on Xeloda for its extended use is expected imminently.

The new Avastin label will allow it to be used in combination with every standard fluoropyrimidine based chemotherapy and also allows for combinations with Xeloda or oxaliplatin. Avastin formerly could only be used in combination with IV 5-FU or IV 5-FU/irinotecan-based chemotherapy regimen2 where it had demonstrated an impressive survival extension of nearly 5 months. Physicians now have the flexibility to use Avastin with a broad variety of standard chemotherapy of their choice in any line of metastatic colorectal cancer.

"This news is highly significant for the estimated 400,000 people diagnosed with metastatic colorectal cancer every year in Europe alone" said William M. Burns, member of the Executive Committee and CEO of the Pharmaceuticals Division at Roche. "This is another milestone in our commitment to developing effective and safe treatments for the large number of colorectal cancer patients throughout the world."

The approval of this broad label is based on the results of two large international phase III pivotal studies (NO16966 and E3200).

"This is a major turning point in the treatment of metastatic colorectal cancer patients," said Professor Alberto Sobrero, Head of Medical Oncology, Hospital San Martino, Genoa, Italy. "This approval means that many more patients can benefit from Avastin's significant survival benefits."