Health Canada Approves AVASTIN in Combination with Carboplatin/Paclitaxel for Treatment of Patients with Non-small Cell Lung Cancer



    
    AVASTIN is now approved to treat three of the top four most prevalent
    cancers in Canada: Lung, Breast and Colorectal Cancer(i)
    

    TORONTO, April 9 /CNW/ - Hoffmann-La Roche Canada (Roche) announced today
that Health Canada has approved AVASTIN(R) (bevacizumab), in combination with
paclitaxel-carboplatin chemotherapy regimen, for treatment of patients with
unresectable advanced, metastatic or recurrent non-squamous non-small cell
lung cancer (NSCLC), the most common form of this devastating disease.
    This approval is based on the pivotal Phase III trial data (E4599) which
demonstrated that  the addition of AVASTIN to the paclitaxel-carboplatin
chemotherapy regimen significantly extended survival to more than one year,
the first therapy to achieve this in NSCLC. Patients receiving AVASTIN plus
paclitaxel-carboplatin also demonstrated more than a doubling in overall
response rates compared to patients that had paclitaxel-carboplatin alone. 
AVASTIN received approval in the United States for the treatment of metastatic
NSCLC in October 2006.
    "Avastin's approval for the treatment of first line-metastatic non-small
cell lung cancer is great news for lung cancer patients in Canada, and even
more so during Cancer Awareness Month," said Dr. Vera Hirsh, Chair, Lung
Cancer Committee, McGill University. "When it comes to metastatic non-small
cell lung cancer, longer survival without progression (and even improvement)
of lung cancer-associated symptoms is a positive health outcome. Avastin is
the first agent when added to chemotherapy that prolongs survival enabling
patients to live longer with a better quality of life."
    AVASTIN is an anti-angiogenic therapy that inhibits the growth of a
network of blood vessels that supply nutrients and oxygen to cancerous
tissues. It is the first in its class shown to consistently deliver improved
overall and/or progression-free survival benefit for colorectal, lung, breast
and renal cell cancer patients. AVASTIN is now approved in Canada to treat
three of the top four most prevalent cancers(ii): lung, breast and colorectal,
satisfying unmet patient needs.
    Lung cancer remains the leading cause of cancer death for both men and
women in Canada and globally. On average, 460 Canadians will be diagnosed with
lung cancer every week and 388 of them will die from it. One in 12 men is
expected to develop lung cancer during their lifetime and one in 13 will die
of it. One in 16 women is expected to develop lung cancer during their
lifetime and one in 18 is expected to die of it.(iii)
    Roche is continuing to study AVASTIN in lung cancer as well as in a
variety of other tumour types. Roche is committed to providing Canadians with
innovative therapies that do not deteriorate their quality of life.

    About the E4599 study

    The Health Canada approval is based on results from the E4599 study - a
randomized, controlled, multi-centre Phase III trial. 878 patients with
locally advanced, metastatic or recurrent NSCLC with histology other than
predominant squamous cell were enrolled into the trial.

    
    The results showed:

    -   Patients receiving AVASTIN at a dose of 15 mg/kg every three weeks
        plus paclitaxel and carboplatin (PC) had a 19 percent improvement in
        overall survival, compared to patients who received chemotherapy
        alone. Median survival was extended beyond one year for patients
        treated with AVASTIN (12.3 vs. 10.3 months).
    -   Overall safety was consistent with the established safety profile
        seen in previous clinical studies associated with either AVASTIN or
        the chemotherapy regimen concomitantly administered in the
        population.

    About AVASTIN

    Data from the comprehensive AVASTIN cancer clinical development programme
have resulted in approvals in advanced colorectal, breast, lung and kidney
cancer:

    -   October 2006 (US) - first-line treatment in patients with advanced
        non-small cell lung cancer (NSCLC)
    -   August 2007 (EU) - first-line treatment in patients with advanced
        NSCLC
    -   February 2004 (US) and January 2005 (EU) - first-line treatment in
        patients with metastatic colorectal cancer (CRC)
    -   September 2005 (CDN) - first line treatment in patients with
        metastatic CRC
    -   June 2006 (US) - second-line treatment in patients with metastatic
        CRC
    -   March 2007 (EU) - first-line treatment in patients with metastatic
        breast cancer
    -   April 2007 (Japan) - treatment in patients with recurrent or advanced
        CRC
    -   December 2007 (EU) - first-line treatment in patients with advanced
        RCC
    -   January 2008 (EU) - first and later-line treatment in patients with
        mCRC in combination with any chemotherapy
    -   February 2008 (US) - first-line treatment in patients with advanced
        breast cancer
    -   February 2009 (CDN) - NOC/c for first-line treatment in patients with
        advanced breast cancer
    -   March 2009 (CDN) - NOC for treatment in patients with unresectable
        advanced, metastatic or recurrent non-squamous non-small cell lung
        cancer (NSCLC)

    Clinical trials have been conducted in patients with various malignancies
treated with AVASTIN, predominantly in combination with chemotherapy. The
safety profile from a clinical trial population of more than 3500 is presented
in the Product Monograph.

    The most serious adverse drug reactions were:

    -   Gastrointestinal Perforations
    -   Haemorrhage including pulmonary haemorrhage/hemoptysis, which is more
        common in NSCLC patients
    -   Arterial Thromboembolism
    -   Non-gastrointestinal Fistula
    -   Hypertensive Crises
    -   Reversible Posterior Leukoencephalopathy Syndrome
    -   Neutropenia and Infections
    -   Nephrotic Syndrome
    -   Congestive Heart Failure
    

    The most frequently observed adverse drug reactions across all clinical
trials in patients receiving AVASTIN were fatigue or asthenia, diarrhea,
hypertension and abdominal pain.

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading
research-focused healthcare groups in the fields of pharmaceuticals and
diagnostics. As the world's biggest biotech company and an innovator of
products and services for the early detection, prevention, diagnosis and
treatment of diseases, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is the world leader in
in-vitro diagnostics and drugs for cancer and transplantation, and is a market
leader in virology. It is also active in other major therapeutic areas such as
autoimmune diseases, inflammatory and metabolic disorders and diseases of the
central nervous system. In 2008, sales by the Pharmaceuticals Division totaled
36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7
billion francs. Roche has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and Chugai, and
invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group
employs about 80,000 people. Additional information is available on the
Internet at www.roche.com.

    
    ----------------------------
    (i)   Canadian Cancer Statistics 2008, Canadian Cancer Society:
          Referenced online on March 27, 2009.
    (ii)  Ibid.
    (iii) Ibid.
    





For further information:

For further information: or to schedule an interview with the medical
oncologist, please contact: Farah Meghji, Hoffmann-La Roche Limited, Tel:
(905) 542-5883, E-mail: farah.meghji@roche.com; Caylyn Rodrigues, Edelman,
Tel: (416) 979-1120 ext. 395, E-mail: caylyn.rodrigues@edelman.com

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