Avastin Receives Positive Opinion in Europe for First-Line Treatment of Patients With Advanced Kidney Cancer

Basel, Switzerland, November 16 (ots/PRNewswire) -

- Avastin Offers Patients the Chance to Live Twice as Long Without
Their Disease Advancing

Roche announced today that the European Committee for Medicinal
Products for Human Use (CHMP) has issued a positive recommendation
for Avastin (bevacizumab) for the first-line treatment of patients
with the most common form of advanced kidney cancer, renal cell
carcinoma (RCC)(1). The CHMP's decision is based on data from the
pivotal phase III AVOREN trial, which showed that adding Avastin to
interferon gave patients with advanced RCC the chance to live twice
as long without their disease progressing ("progression free
survival") compared with interferon (IFN) alone.

"The AVOREN study has shown us that Avastin is an effective and
safe treatment for patients with kidney cancer," said Professor
Bernard Escudier, Head of Immunotherapy and Innovative Therapy Unit,
Institut Gustave-Roussy, Paris, France and Principal Investigator of
the pivotal AVOREN study. "This announcement is very significant
because this drug offers new therapeutic options in advanced kidney
cancer, where chemotherapy and radiotherapy are not as effective as
in other cancers."

On an annual basis, in excess of 200,000 people worldwide will
receive a diagnosis of kidney cancer and more than 100,000 people
worldwide will lose their lives to the disease(i). These figures can
be expected to increase as the number of people suffering from cancer
in general rises by 50%, as recently estimated by the WHO(ii).

Avastin Approval Status

Kidney cancer is the fourth cancer type in which Avastin has
demonstrated survival benefits. Data from the comprehensive Avastin
cancer clinical development programme have resulted in approvals in
colorectal, breast, and lung:

- February 2004 (US) and January 2005 (EU) - first-line
treatment in patients with metastatic colorectal cancer

- June 2006 (US) - second-line treatment in patients with
metastatic colorectal cancer

- October 2006 (US) - first-line treatment in patients with
advanced non-small cell lung cancer (NSCLC)

- March 2007 (EU) - first-line treatment in patients with
metastatic breast cancer

- April 2007 (Japan) - recurrent or advanced treatment in patients
with advanced colorectal cancer

- August 2007 (EU) - first-line treatment in patients with
advanced NSCLC

About the AVOREN Study

The AVOREN study is a randomised, controlled, double-blind phase
III study that included 649 patients from 101 study sites across 18
countries. In the study patients received treatment with either
Avastin and interferon alpha-2a or placebo and interferon alpha-2a, a
standard of care in advanced kidney cancer.

The results of the AVOREN trial showed that by adding Avastin to
IFN (a current standard of care):

- Progression free survival was almost doubled from a median of
5.4 to 10.2 months

- Tumour response was significantly increased from 12.8% with
interferon alone to 31.4% when Avastin was added

- Dose-reduction of IFN did not appear to affect the efficacy of
the combination of Avastin (based on PFS event free rates over time,
as shown by a sub-group analysis)

The study also showed a trend towards improved overall survival;
however, the survival data are still pending. No new or unexpected
adverse events were observed.

An interim analysis of AVOREN was performed in December 2006 and
the benefits provided by Avastin were so positive that the Drug
Safety Monitoring Board (DSMB) recommended that the trial was
unblinded and all patients were offered treatment with Avastin. The
study demonstrated, for the first time that Avastin also benefits
patients in combination with an immunotherapeutic, the class of drugs
to which IFN belongs.

About Kidney Cancer

Kidney cancer is more common in men than women (approximately 62%
of patients with RCC are male) and incidence increases with age(i).

As the most common type of kidney cancer, RCC accounts for nine
out of ten cases of the disease. Within this cancer type, there are
several sub-types of cancer based on looking at the cells under a
microscope. Clear cell renal cell cancer is the most common type. If
RCC is diagnosed at an early stage when the cancer is still confined
to the kidney, the 5 year survival rates are relatively good at 60 to
75%. However, if diagnosis is made at a later stage and the cancer
has already spread to distant sites the 5 year survival rate is less
than 5%(iii). Unfortunately, because kidney cancer is often
asymptomatic, the majority of patients are diagnosed at later disease
stages.

Treatment options for patients with kidney cancer are limited.
Surgical removal of part or the entire kidney forms the mainstay of
treatment but is only really successful in early stage disease. In
later stage disease, treatment is more often employed with a view of
controlling the cancer and improving associated symptoms.

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

---------------------------------

(1) The positive opinion is for the use of Avastin in patients
with advanced clear cell RCC in combination with interferon, the
current standard of care.

---------------------------------

(i) Parkin DM, Bray F, Ferlay J and Pisani P. Global cancer
statistics 2002. CA Cancer J Clin 2005; 55; 74 - 108.

(ii) WHO Information sheet on cancer
http://www.who.int/dietphysicalactivity/publications/facts/cancer/en/
(accessed 24 May 2007)

(iii) Medline Plus
http://www.nlm.nih.gov/medlineplus/ency/article/000516.htm#Causes
,%20incidence,%20and%20risk%20factors (accessed 15 August 2007) (copy
and paste this URL into your browser)

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

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