Health Canada Approves Avastin in Combination with Paclitaxel for First-Line Treatment of Patients with Advanced HER2-Negative Breast Cancer

    Avastin is now approved to treat the two most prevalent cancers in
    Canada: Breast and Colorectal Cancer(1)

    TORONTO, Feb. 11 /CNW/ - Hoffmann-La Roche Canada (Roche) announced today
that Health Canada has approved Avastin(R) (bevacizumab), in combination with
paclitaxel chemotherapy, for the first-line treatment of patients with
metastatic HER2-negative breast cancer who are ECOG Class 0-1. The approval,
under the policy of Notice of Compliance with Conditions, is based on results
of a phase III study (E2100), which showed the combination of Avastin and
paclitaxel nearly doubled the chance of progression-free survival in patients
with metastatic breast cancer compared to paclitaxel alone.
    "Health Canada's approval of Avastin for first-line metastatic breast
cancer is another important advancement in breast cancer therapy in Canada and
excellent news for patients with the disease," said Dr. Karen Gelmon, medical
oncologist, BC Cancer Agency and Professor of Medicine, University of British
Columbia. "In the study patients on the Avastin-paclitaxel combination therapy
experienced a doubling of their time living without the disease advancing.
This may provide a significant increase in the quality time for patients."
    Products authorized under Health Canada's NOC/c policy are intended for
the treatment, prevention or diagnosis of a serious, life-threatening or
severely debilitating illness. They have demonstrated promising benefit, are
of high quality and possess an acceptable safety profile based on a
benefit/risk assessment. Health Canada has provided access to this product on
the condition that the sponsor submit the results of additional clinical
trials to verify the benefit within an agreed upon time frame.
    "This is exceptionally good news for Canadian women with metastatic
breast cancer," says Diana Ermel, President of the Canadian Breast Cancer
Network. "It represents another advance in breast cancer treatment."
    Roche will undertake additional studies to verify the clinical benefit of
Avastin for HER-2 negative breast cancer patients. Roche will provide Health
Canada with the results of two confirmatory phase III trials: AVADO (Avastin
plus docetaxel chemotherapy vs. docetaxel alone) which has already
demonstrated superior efficacy and safety of the combination, and RIBBON-1. A
full review of both the AVADO and RIBBON-1 data by Health Canada will be
required for the NOC/c to be converted into a full Notice of Compliance.
    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
two of the most prevalent forms of cancers in Canada: breast and colorectal
cancers(2), satisfying unmet patient needs. Avastin received accelerated
approval in the United States for the treatment of metastatic breast cancer in
February 2008 and approval in Europe in March 2007.
    Breast cancer is the most common cancer in Canadian women. All women are
exposed to the potential of breast cancer - one out of eight women will
develop breast cancer at some point in her lifetime and 40% of them will end
in metastasis. Breast cancer affects younger women more frequently than all
other cancer types together. In 2008, an estimated 22,400 women were diagnosed
with breast cancer in Canada and approximately 5,300 died from the disease(3).
Globally, breast cancer is the second most common form of cancer and the
second leading cancer killer of women with an estimated annual death toll in
excess of 400,000(4).
    Roche is continuing to study Avastin in early-stage breast cancer as well
as in a variety of other tumour types. Avastin is the second biologic therapy
to be discovered and developed by Genentech/Roche for women with advanced
breast cancer. Roche is committed to providing Canadians with innovative
therapies that do not deteriorate the quality of life.

    About E2100

    The E2100 trial was sponsored by the National Cancer Institute under a
Cooperative Research and Development Agreement and was conducted by a network
of researchers led by the Eastern Cooperative Oncology Group (ECOG). E2100 was
a multicentre, randomized and controlled clinical trial that enrolled 772
patients with previously untreated, locally recurrent or metastatic breast
cancer. Patients were randomized to receive weekly treatment with paclitaxel
every three out of four weeks, with or without Avastin administered once every
two weeks.
    Based on an independent, blinded review of patient scans, patients
treated with Avastin plus paclitaxel experienced a 52 percent reduction in the
risk of disease progression or death compared to those treated with paclitaxel
alone (based on a hazard ratio of 0.48; p (less than)0.0001). In the Avastin
arm, median PFS was 11.3 months versus 5.8 months in the paclitaxel alone arm.
Based on the investigator assessment, patients treated with Avastin plus
paclitaxel experienced a 58 percent reduction in the risk of disease
progression or death compared to those treated with paclitaxel alone (based on
a hazard ratio of 0.42; p (less than)0.0001). The data showed a similar
magnitude of benefit relative to the initial results presented by ECOG at the
American Society of Clinical Oncology annual meeting in 2005 and later
published in the New England Journal of Medicine in 2007. The secondary
endpoint of overall survival was longer in the Avastin-containing arm, as
indicated by the hazard ratio of 0.87 but this improvement did not reach
statistical significance (p=0.14). A one year exploratory analysis of overall
survival was significantly improved with the addition of Avastin, (73.8% vs.
82.3%; p=0.007).
    Overall, the safety profile of AVASTIN seen in the pivotal study was
consistent with the established safety profile seen in previous phase III
studies in other tumor types. A 20% increase in grade 3 and 4 adverse events
was observed in the AVASTIN plus paclitaxel arm compared to paclitaxel alone
which was mainly driven by hypertension. The most serious AEs described in the
Product Monograph1 include gastrointestinal perforations, hemorrhage, arterial
hromboembolism, non-gastrointestinal fistula, hypertensive crises, reversible
posterior leukoencephalopathy syndrome, neutropenia and infections, nephritic
syndrome and congestive heart failure. The most frequently observed AEs with
(greater than)2% difference between treatment arms across clinical trials in
metastatic breast cancer patients receiving AVASTIN, with or without
chemotherapy, were hypertension (very common), fatigue or asthenia, infection,
neutrophil count abnormalities, nausea, vomiting, diarrhoea, dehydration,
headache, peripheral sensory neuropathy and proteinuria.

    About Avastin

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

    -   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

    -   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

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

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

    -   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

    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 totalled
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

    (1) Canadian Cancer Statistics 2008, Canadian Cancer Society: Referenced
        online on January 23, 2009
    (2) Ibid.
    (3) Breast Cancer Statistics 2008, Canadian Cancer Society: Referenced
        online on January 27, 2009
    (4) Parkin M, Bray F, Ferlay J, and Pisani P: CA Cancer J Clin

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:; Caylyn Rodrigues, Edelman,
Tel.: (416) 979-1120 ext. 395, E-mail:

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