BASEL, Switzerland, August 24 /PRNewswire/ --

- First Medicine Shown to Extend Survival Beyond One Year in Previously 
Untreated Lung Cancer Patients

Avastin (bevacizumab), Roche's innovative anti-cancer drug, was approved
today in Europe for the first-line treatment of patients with advanced
non-small cell lung cancer (NSCLC), in combination with platinum-based
chemotherapy.

NSCLC is the most common form of lung cancer, a difficult to treat
disease that kills over 3,000 people per day worldwide.(1) NSCLC is usually
diagnosed at an advanced stage, meaning individuals diagnosed with the
disease typically have a life expectancy of only 8 to 10 months.(2),(3) 
Avastin is the only first-line therapy to demonstrate improved survival 
benefits beyond one year in patients with advanced NSCLC.

The approval is based on data from the pivotal US phase III trial (E4599)
and the 'Avastin in Lung' (AVAiL) phase III trial. Both studies demonstrate
that Avastin is effective for the treatment of patients with NSCLC in
combination with platinum-based chemotherapy. The approval is for the use of
Avastin at a dose of 7.5 or 15 mg/kg, in combination with platinum-based
chemotherapy, for the first-line treatment of patients with unresectable
advanced, metastatic or recurrent NSCLC other than predominantly squamous
cell histology. The broad label that Avastin has received for the treatment
of NSCLC allows the combination of Avastin with any platinum-based
chemotherapy regimens (for example, together with taxanes or gemcitabine) at
the choice of the physician.

Professor Christian Manegold, Professor of Medicine at Heidelberg
University, University Medical Center Mannheim, Germany and Principal
Investigator of the AVAiL trial, was enthusiastic about the news: "Lung
cancer is an extremely difficult disease to treat and Avastin has proven that
it can prolong the life of patients with NSCLC. A treatment like Avastin that
breaks through the one year survival barrier is a big step forward. The
European approval for Avastin means we can reassess our expectations for lung
cancer patient survival."

Avastin is the first and only anti-angiogenic agent which has been shown
to consistently deliver improved overall and/or progression-free survival for
patients with colorectal, lung, breast and kidney cancer.

About the Phase III studies that formed the basis of the approval

E4599 study

The results of the randomised, controlled, multicentre phase III E4599
study of 878 patients with locally advanced, metastatic or recurrent NSCLC,
with histology other than predominant squamous cell, show that median
survival of patients treated with Avastin at a dose of 15 mg/kg every three
weeks plus chemotherapy was 12.3 months, compared to 10.3 months for patients
treated with chemotherapy alone. Patients receiving Avastin in combination
with paclitaxel and carboplatin had a 25% improvement in overall survival
compared to patients who received chemotherapy alone. Side effects were
generally manageable. Pulmonary haemorrhage/ haemoptysis cases were observed
in 2.3% of the patients receiving Avastin plus chemotherapy. The most common
adverse events associated with Avastin therapy were: hypertension (5.6%),
proteinuria (4.2%), fatigue (5.1%) and dyspnoea (5.6%).(4)

AVAiL study

In the double-blind, randomised, controlled, phase III AVAiL study,
patients received treatment with either Avastin at 7.5mg/kg or 15mg/kg +
cisplatin/gemcitabine or placebo + cisplatin/gemcitabine. The study involved
more than 1,000 patients world-wide with previously untreated advanced NSCLC,
with histology other than predominant squamous cell. The results show that by
adding Avastin to a cisplatin/gemcitabine regimen progression-free survival
was significantly prolonged by 20 to 30% compared with chemotherapy alone. No
new or unexpected adverse events were observed.

All trademarks used or mentioned in this release are protected by law.

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, in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com.

References

(1). Kamangar F, et al. Patterns of cancer incidence, mortality, and
prevalence across five continents: defining priorities to reduce cancer
disparities in different geographic regions of the world. J Clin Oncol 2006;
24(14): 2137-50.

(2). Schiller JH, et al. Comparison of four chemotherapy regimens for
advanced non-small-cell lung cancer. N Engl J Med 2002;346:92-8.

(3). Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab 
for Non-Small-Cell Lung Cancer. N Engl J Med. 2006:355; 2542-50

(4). Data on file. Roche, 2006