Avastin Approved 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, Dec. 19 /CNW/ - Avastin (bevacizumab), Roche's
innovative anti-cancer drug, was approved today in Europe for the first-line
treatment of patients with advanced renal cell cancer (RCC) in combination
with interferon (IFN), the current standard of care(*). Kidney cancer, known as
renal cell carcinoma (RCC) is a disease that kills over 100,000 people per
year world-wide(1).
    There are few early symptoms in kidney cancer which means that
unfortunately the majority of patients are diagnosed with advanced disease,
where current treatment options are limited. Kidney cancer is highly resistant
to chemotherapy and radiotherapy, which are often key weapons against other
cancer types(2).
    The approval was based on data from the pivotal phase III AVOREN trial,
which showed that patients with advanced RCC who received Avastin in
combination with IFN lived nearly twice as long without their disease
progressing ("progression free survival"), as those who received IFN alone.
    "The results of the AVOREN study confirmed that Avastin is a safe,
effective and well tolerated treatment option for patients with advanced renal
cell cancer," said Professor Bernard Escudier, Head of the Immunotherapy and
Innovative Therapy Unit, Institut Gustave-Roussy, Paris, France and Principal
Investigator of the pivotal AVOREN study. "Avastin effectively doubles the
time in which patients live without their disease getting worse, so this
approval has the potential to change the treatment landscape for this disease,
where treatment options are still limited."

    Avastin Approval Status

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

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

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

    -   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) - treatment in patients with recurrent or
        advanced CRC

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

    -   December 2007 (EU) - first-line treatment in patients with
        advanced RCC

    About the AVOREN Study

    The AVOREN study is a randomised, controlled, double-blind, phase III
study that included 649 patients with advanced kidney cancer from 101 study
sites across 18 countries. Study participants received treatment with either
Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in
patients with advanced kidney cancer.
    The results of the AVOREN trial showed that by adding Avastin to IFN:

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

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

    -   Dose-reduction of IFN did not appear to affect the efficacy of the
        combination with 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,
these 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 recommended that the trial was unblinded and all patients were offered
treatment with Avastin. The study demonstrated for the first time that Avastin
benefits patients in combination with an immunotherapeutic, the class of drugs
to which IFN belongs.


    1.  Parkin DM, Bray F, Ferlay J and Pisani P. 2002. CA Cancer J Clin,
        2005; 55: 74-108.

    2.  De Mulder, PHM. Ann Oncol, 2007; 18 (Supplement 9): ix98-ix102.


    (*) The approval is for the use of Avastin in patients with advanced
        and/or metastatic RCC in combination with IFN.

For further information:

For further information: Roche, Erica Bersin, +41-61-688-2164 (direct),
+41-79-618-7672 (mobile); Galliard Healthcare, Jon Harris, +44-20-7663-2261

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