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

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

November 17, 2007

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

    BASEL, Switzerland, Nov. 17 /Xinhua-PRNewswire/ --
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)(*).
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

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

    (*) 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)


    For more information, please contact:

     Erica Bersin 
     Roche
     Tel:    [phone] 
     Mobile: [phone] 

     Jon Harris 
     Galliard Healthcare
     Tel:    [phone]