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Avastin receives broad label extension in Europe for the treatment of patients with metastatic colorectal cancer


Many more patients can now benefit from Avastin’s proven survival benefits

Roche announced today 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. 1

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.”

About the Phase III studies that formed the basis of the approval
Note: Progression-free survival is a measure of the time patients live without their disease advancing.

NO16966 study
NO16966 is a large, international phase III trial which recruited 2,034 patients. It was originally planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer. After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate using a 2 by 2 factorial design: FOLFOX/XELOX + placebo vs FOLFOX/XELOX + Avastin.

The primary objective was to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved progression-free survival compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile. Results of the study showed:

* The addition of Avastin to chemotherapy (XELOX or FOLFOX-4) significantly improved progression-free survival by 20% compared with chemotherapy alone.
* In patients that received treatment until disease progression, the benefit was even greater, and adding Avastin to chemotherapy improved progression-free survival by 58%.
* The chemotherapy combination XELOX is as effective in terms of progression-free survival as FOLFOX.

E3200 study
The E3200 study is a randomized, controlled, multi-center phase III trial of 829 patients with advanced or metastatic colorectal cancer who had received previous treatment with irinotecan and 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death (based on a hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 12.9 months, compared to 10.8 months for those receiving FOLFOX4 alone.


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