Avastin(R) Receives Positive Opinion in Europe for First-Line Treatment of Patients With Advanced Lung Cancer

Basel, Switzerland (ots/PRNewswire) -

- First Medicine Shown to Extend Survival of Previously Untreated
Patients Beyond One Year

Roche announced today that the European Committee for Medicinal
Products for Human Use (CHMP) has issued a positive recommendation
for the first-line use of Avastin in the treatment of the most common
form of lung cancer, in combination with platinum-based
chemotherapy.* The CHMP's decision is based on data from the pivotal
US (E4599) study and another phase III Avastin in Lung (AVAiL) study
which together demonstrate that Avastin is effective in combination
with a broad chemotherapy range.

Lung cancer is responsible for over 3,000 deaths per day
world-wide(1) and non-small cell lung cancer (NSCLC) is the most
common form of the disease accounting for more than 80 percent of all
lung cancers.(2) Avastin is the only first-line treatment in over a
decade that has been shown to extend the life of patients with
advanced lung cancer in a disease for which patients typically have
an average life expectancy of only 8 to 10 months.

"This is a significant day for healthcare professionals and
patients as it brings access to Avastin, with its proven ability to
extend life in an extremely difficult to treat disease, one step
closer to reality" said Professor Christian Manegold, Professor of
Medicine, Heidelberg University, University Medical Center, Mannheim,
Germany and Principal Investigator of the AVAiL study. "I believe
that Avastin is such an innovative treatment that it will change not
only the current standard of care in NSCLC, but it will also re-write
our expectations for patient outcomes."

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

"The CHMP opinion is encouraging news for European patients
fighting a particularly aggressive and debilitating disease," said
William M. Burns, CEO Pharmaceuticals Division of Roche. "With our
Avastin development program - the biggest trial program in oncology
ever - we will continue to develop the best possible treatment
approaches to increase survival and improve quality of life of cancer
patients."

In Europe, Avastin was approved in January 2005 and in the US in
February 2004 for first-line treatment of patients with metastatic
colorectal cancer. It received another approval in the US in June
2006 as a second-line treatment for patients with metastatic
colorectal cancer. In October 2006, following priority review, the
world's first angiogenesis inhibitor was approved by the FDA for the
treatment of NSCLC. Most recently in April 2007, Avastin was approved
in Europe for the first line treatment of women with metastatic
breast cancer and in Japan for use in advanced or recurrent
colorectal cancer.

About the Phase III studies that formed part of the data pack
submitted to the CHMP

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 at a dose of 15 mg/kg every three weeks
plus 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 monotherapy were: hypertension (5.6%), proteinuria
(4.2%), fatigue (5.1%) and dyspnoea (5.6%).(3)

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.

Additional information

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

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

- Avastin: www.avastin-info.com

References

1. Kamangar F, Dores GM, Anderson WF. 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. Wilking N and Jonsson B. A Pan-European comparison regarding
patient access to cancer drugs. Karolinska Institute in collaboration
with Stockholm School of Economics, Stockholm, Sweden, 2005.

3. Data on file. Roche, 2006

* The positive opinion is for the use of Avastin, in combination
with platinum-based chemotherapy, for first-line treatment of
patients with unresectable advanced, metastatic or recurrent
non-small cell lung cancer other than predominantly squamous cell
histology.

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

Contact:
For more information please contact: Roche, Erica Bersin.
+41-61-688-2164 (direct), +41-79-618-7672 (mobile); Galliard
Healthcare, Jon Harris, +44-(0)207-663-2261 (direct)


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