Avastin Approved in Europe for First-line Treatment of Patients With Advanced Lung Cancer

    BASEL, Switzerland, Aug. 24 /CNW/ -

    - First Medicine Shown to Extend Survival Beyond One Year in Previously
Untreated Lung Cancer Patients

    Avastin (bevacizumab), Roche's innovative anti-cancer drug, was approved
today in Europe for the first-line treatment of patients with advanced
non-small cell lung cancer (NSCLC), in combination with platinum-based
    NSCLC is the most common form of lung cancer, a difficult to treat
disease that kills over 3,000 people per day worldwide.(1) NSCLC is usually
diagnosed at an advanced stage, meaning individuals diagnosed with the disease
typically have a life expectancy of only 8 to 10 months.(2),(3) Avastin is the
only first-line therapy to demonstrate improved survival benefits beyond one
year in patients with advanced NSCLC.
    The approval is based on data from the pivotal US phase III trial (E4599)
and the 'Avastin in Lung' (AVAiL) phase III trial. Both studies demonstrate
that Avastin is effective for the treatment of patients with NSCLC in
combination with platinum-based chemotherapy. The approval is for the use of
Avastin at a dose of 7.5 or 15 mg/kg, in combination with platinum-based
chemotherapy, for the first-line treatment of patients with unresectable
advanced, metastatic or recurrent NSCLC other than predominantly squamous cell
histology. The broad label that Avastin has received for the treatment of
NSCLC allows the combination of Avastin with any platinum-based chemotherapy
regimens (for example, together with taxanes or gemcitabine) at the choice of
the physician.
    Professor Christian Manegold, Professor of Medicine at Heidelberg
University, University Medical Center Mannheim, Germany and Principal
Investigator of the AVAiL trial, was enthusiastic about the news: "Lung cancer
is an extremely difficult disease to treat and Avastin has proven that it can
prolong the life of patients with NSCLC. A treatment like Avastin that breaks
through the one year survival barrier is a big step forward. The European
approval for Avastin means we can reassess our expectations for lung cancer
patient survival."
    Avastin is the first and only anti-angiogenic agent which has been shown
to consistently deliver improved overall and/or progression-free survival for
patients with colorectal, lung, breast and kidney cancer.

    About the Phase III studies that formed the basis of the approval

    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 in combination with
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 therapy were: hypertension (5.6%), proteinuria
(4.2%), fatigue (5.1%) and dyspnoea (5.6%).(4)

    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.

    All trademarks used or mentioned in this release are protected by law.

    Additional information

    - Roche in Oncology:
    - Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs
    - Avastin: http://www.avastin-info.com

    To access video clips about Avastin, in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com.


    (1). Kamangar F, et al. 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). Schiller JH, et al. Comparison of four chemotherapy regimens for
         advanced non-small-cell lung cancer. N Engl J Med 2002;346:92-8.
    (3). Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab
         for Non-Small-Cell Lung Cancer. N Engl J Med. 2006:355; 2542-50
    (4). Data on file. Roche, 2006

For further information:

For further information: Roche, Erica Bersin, Erica.Bersin@Roche.com;
Galliard Healthcare, Dominic Elliston, +44-(0)207-663-2266 (direct),

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