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

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

    BASEL, Switzerland, Nov. 16 /CNW/ - 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

    -   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

    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
    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:

    -   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
    (accessed 24 May 2007)

    (iii) Medline Plus
    (accessed 15 August 2007) (copy and paste this URL into your browser)

For further information:

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

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