Many More Patients Can Now Benefit From Avastin's Proven Survival Benefits

Basel, Switzerland (ots/PRNewswire) -

- Avastin Receives Broad Label Extension in Europe for the
Treatment of Patients With Metastatic Colorectal Cancer

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
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 regimen (2) 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 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."

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

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.

Additional information

- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk, Cancer:
http://www.health-kiosk.ch/start_krebs

- Avastin: http://www.avastin-info.com

To access video clips about Avastin and Xeloda, in broadcast
standard, free of charge, please go to: http://www.thenewsmarket.com.

References

(1) Ferlay J, AutierP et al. Annals of Oncology 18: 581-592, 2007.

(2) Hurwitz H, Fehrenbacher L, Novotny W et al. New England
Journal of Medicine 2004; 350(23): 2335-42.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

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For more information please contact: Roche, Erica Bersin,
+41-61-688-2164, Erica.Bersin@Roche.com. Galliard Healthcare: Dominic
Elliston, +44-207-663-2266, Delliston@galliardhealth.com


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