Health Canada approves new chemotherapy treatment for patients with metastatic colorectal cancer



    LAVAL, QC, June 18 /CNW/ - Health Canada has approved Eloxatin(R)
(oxaliplatin for injection) in combination with 5-fluorouracil (5-FU) and
leucovorin (LV) (FOLFOX4) for use in first and second-line treatment of
metastatic colorectal cancer. Clinical studies show that Eloxatin(R) in
combination with 5-FU and LV (FOLFOX4) can prolong survival, shrink tumours
and delay the progression of disease in patients with metastatic colorectal
cancer.(1) In Canada, colorectal cancer is the second-leading cause of death
from cancer.(2) Close to 50 per cent of patients diagnosed with colorectal
cancer go on to develop metastatic colorectal cancer.(3)
    "Combination therapies including Eloxatin are playing an active and
current role in treatment for colorectal cancer," says Barry Stein, President
of the Colorectal Cancer Association of Canada, and colorectal cancer
survivor. "As someone who has gone through the process of finding an effective
treatment for colorectal cancer, I am encouraged that the approval of Eloxatin
will offer new hope for Canadians who suffer from this disease."
    Eloxatin(R), manufactured by sanofi-aventis, is a platinum agent and is
one of the first treatments in its class to show a significant level of
activity in metastatic colorectal cancer.

    Clinical Data

    In an international clinical trial with Canadian investigation sites,
patients with previously untreated metastatic colorectal cancer, receiving
FOLFOX4 had a median survival of 19.4 months whereas those patients treated
with irinotecan plus bolus 5-FU/LV (IFL) had a median survival of 14.6 months;
p (less than) 0.0001. Patients treated with FOLFOX4 had a significantly higher
overall response rate (p = 0.0075) and a longer time to disease progression
(8.7 months vs. 6.9 months; p = 0.0014).(4)
    Additional clinical data have shown that in previously treated metastatic
colorectal cancer, FOLFOX4 is superior to infusional 5-FU/LV in terms of time
to progression and response rate. In a clinical trial, the median time to
progression for FOLFOX4 was 5.3 months versus 2.6 months for 5-FU/LV   (p =
0.001). Patients treated with FOLFOX4 also had a significantly higher overall
response rate (p = 0.001). (1),(4) Eloxatin(R)-based chemotherapy has also
been shown to be as effective in patients older than 65 as it is in younger
individuals.
    "Treating patients with combination Eloxatin offers my patients new hope
of improving their survival time," says Dr. Scot Dowden, a medical oncologist
with the Tom Baker Cancer Centre in Calgary. "This is an important advance in
the management of metastatic colorectal cancer."

    About Eloxatin(R)

    Eloxatin(R) is one of the first treatments in its class (DACH-platinum)
to show a significant level of activity in metastatic colorectal cancer. The
platinum attached to Eloxatin(R) binds to the DNA in cancer cells, disrupting
the cells' ability to reproduce.
    Eloxatin(R) is currently available in more than 60 countries. In Canada,
Eloxatin(R) in combination with infusional 5-FU and LV (FOLFOX4), is now
indicated for the treatment of metastatic colorectal cancer. Eloxatin(R) in
combination with 5-FU/LV (FOLFOX4) in the treatment of metastatic colorectal
cancer is given every 14 days.
    Side effects observed in the clinical trial setting included: fatigue,
neuropathy, nausea, vomiting, diarrhea, stomatitis, neutropenia,
thrombocytopenia, anemia, abnormalities of the liver function and respiratory
problems. Anaphylactic reactions have been reported and may occur within
minutes of Eloxatin(R) administration. Eloxatin(R) should be administered
under the supervision of a qualified physician experienced in the use of
cancer chemotherapeutic agents.
    Sanofi-aventis has also filed a dossier to Health Canada for Eloxatin(R)
in the adjuvant setting for colon cancer. This dossier is currently under
review.

    About Colorectal Cancer in Canada

    In 2007, an estimated 20,800 Canadians will be diagnosed with colorectal
cancer and an estimated 8,700 will die from the disease. Of the 8,700
estimated deaths, about 46 per cent will be women and 54 per cent men.(2)
    One in 16 women is expected to develop colorectal cancer during her
lifetime and one in 31 will die from the disease. One in 14 men is expected to
develop colorectal cancer during his lifetime and one in 28 will die from the
disease.(2)
    Metastases are present in about 25 per cent of patients with colorectal
cancer at diagnosis where the average spontaneous rate of survival is limited
to five-to-six months. The primary site of metastasis is in the liver with 50
to 70 per cent of patients having hepatic metastasis during the course of
their cancer.

    About sanofi-aventis

    Sanofi-aventis is one of the world's leading pharmaceutical companies.
Backed by a world-class R&D organization, sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular, thrombosis,
oncology, metabolic diseases, central nervous system, internal medicine, and
vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE:  SNY).
    In Canada, sanofi-aventis employs more than 1,140 people and is
headquartered in Laval, Quebec.
    This year marks a significant milestone as sanofi-aventis is celebrating
its 50th anniversary in oncology research and treatment.

    
    References:
    1.  Rothenberg ML, Oza AM, Bigelow RH, et al. Superiority of oxaliplatin
        and fluorouracil-leucovorin compared with either therapy alone in
        patients with progressive colorectal cancer after irinotecan and
        fluorouracil-leucovorin: interim results of a phase III trial.
        Journal of Clinical Oncology. 2003 Jun 1;21(11):2049-51.
    2.  Canadian Cancer Society.
http://www.cancer.ca/vgn/images/portal/cit_86751114/36/15/1816216925
cw_2007stats_ en.pdf .
    3.  http://www.phac-aspc.gc.ca/publicat/cdic-mcc/24-4/c_e.htm
        Accessed on: May 4, 2007.
    4.  Eloxatin(R) (oxaliplatin for injection) Product Monograph dated
        June 15, 2007, sanofi-aventis Canada Inc.
    




For further information:

For further information: or to book an interview with a physician or
Barry Stein, please contact: Pamela Pavlik, sanofi-aventis Canada Inc., Laval,
QC, pamela.pavlik@sanofi-aventis.com, (514) 856-3832; Sarah Habib, MS&L,
Toronto, ON, sarah.habib@mslpr.ca, (416) 847-1318

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