Health Canada Approves Rituxan for Treatment of Most Common Adult Leukemia



    
    Approval of Rituxan offers Canadians with Chronic Lymphocytic Leukemia a
    new Treatment Option for the Disease
    

    MISSISSAUGA, ON, Aug. 17 /CNW/ - Hoffmann-La Roche Canada (Roche)
announced today that Health Canada has approved Rituxan(R) (rituximab) in
combination with chemotherapy Fludarabine (F) and Cyclophosphamide (C), also
known as FC chemotherapy, for use in patients with previously-untreated
chronic B-cell lymphocytic leukemia (CLL stage B or C), the most common type
of leukemia to affect adults.(1) The approval is based on results from the
pivotal phase III study CLL8.
    "Chronic lymphocytic leukemia is a serious disease affecting more adults
in the Western world than any other form of leukemia," said Dr. Laurie Sehn,
Medical Oncologist at the BC Cancer Agency, and Clinical Assistant Professor
at the University of British Columbia. "Health Canada's approval of Rituxan in
combination with chemotherapy will provide Canadians living with CLL with a
more effective and durable treatment alternative compared with chemotherapy
alone."
    Results from the CLL8 trial showed that patients receiving Rituxan in
combination with FC chemotherapy as first-line treatment lived an average of
40 months without their cancer progressing compared to an average of 32 months
for patients receiving FC chemotherapy alone.(2) At present, CLL is considered
incurable and the aim of treatment is to control the disease by managing
symptoms and extending the time patients live without their disease worsening.
The results of CLL8 demonstrate that patients treated with Rituxan lived
longer without their disease progressing.
    Updated CLL8 trial data was presented at the 2008 American Society of
Hematology Annual Meeting. This updated data showed patients receiving Rituxan
in combination with FC chemotherapy as first-line treatment now lived an
average of 42 without their cancer progressing compared to an average of 42
months for patients receiving chemotherapy alone.(3)
    "Informed patients see Rituxan as the gold standard in therapy that has
eluded us for far too long," said Elizabeth Locatelli, CLL Patient Advocacy
Group (CLLPAG) Board Chair. "Since beginning my Rituxan in combination with
chemotherapy, my white blood cell counts have already returned to normal. Now,
I have the energy to play with my grandsons, and I'm very optimistic that I'll
have an excellent chance to be able to watch them grow up."
    Chronic lymphocytic leukemia (CLL) is the most common adult leukemia in
the Western world, with an incidence in Canada of 4.65/100,000. The incidence
is higher in males (6.28/100,000) than females (3.34/100,000). The disease is
rare in persons less than 30 years of age, and its incidence increases after
age 40. In 50- to 54-year-olds, rates are lower at 4.43/100,000, but increase
to 32.89/100,000 in 75- to 79-year-olds.(4)

    About CLL8

    The CLL8 study is an international study conducted by the German CLL
Study Group and Professor Michael Hallek (University Hospital Cologne,
Germany) in collaboration with Roche. It included 817 patients with CLL
receiving first-line treatment. The study was conducted at 190 study sites
across 11 countries. In this randomized study, patients received either
Rituxan in combination with FC chemotherapy (fludarabine and cyclophosphamide)
or chemotherapy alone. The primary endpoint of the study was progression-free
survival. No new or unexpected safety signals were observed.

    About Rituxan

    Rituxan is a therapeutic antibody that binds to a particular protein -
the CD20 antigen - on the surface of normal and malignant B-cells. It then
recruits the body's natural defences to attack and kill the marked B-cells.
Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing
healthy B-cells to regenerate after treatment and return to normal levels
within several months.

    
    In Canada, Rituxan is approved for:

    1. The treatment of patients with relapsed or refractory low grade or
       follicular, CD20 positive, B-cell non-Hodgkin's lymphoma.

    2. The treatment of patients with CD20 positive, diffuse large B-cell
       non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide,
       doxorubicin, vincristine, and prednisone) chemotherapy.

    3. The treatment of patients with previously untreated Stage III/IV
       follicular, CD20 positive, B-cell non-Hodgkin's lymphoma in
       combination with CVP (cyclophosphamide, vincristine and prednisolone)
       chemotherapy.

    4. The maintenance treatment of patients with follicular non-Hodgkin's
       lymphoma who have responded to induction therapy with either CHOP or
       CHOP plus rituximab.

    5. In combination with methotrexate to reduce signs and symptoms in adult
       patients with moderately to severely active rheumatoid arthritis who
       have had an inadequate response or intolerance to one or more tumour
       necrosis factor (TNF) inhibitor therapies.(5)
    

    Rituxan is known as MabThera in the European Union. To date, more than
1.5 million patients have been treated with Rituxan worldwide.
    Genentech and Biogen Idec co-market Rituxan in the United States, and
Roche markets MabThera in the rest of the world, except Japan, where MabThera
is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

    About Roche

    Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company with truly
differentiated medicines in oncology, virology, inflammation, metabolism and
CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based
cancer diagnostics and a pioneer in diabetes management. Roche's personalized
healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients.
    In 2008, Roche had over 80,000 employees worldwide and invested almost 9
billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss
francs. Genentech, United States, is a wholly owned member of the Roche Group.
Roche has a majority stake in Chugai Pharmaceutical, Japan. For more
information, visit www.roche.com.

    References:

    
    -------------------------
    (1) Canadian Cancer Society. Chronic lymphocytic leukemia overview.
    http://info.cancer.ca/E/CCE/cceexplorer.asp?tocid=66. Accessed
    August 6, 2009.
    (2) Rituxan Product Monograph, August 7, 2009
    (3) Rituxan Product Monograph, August 7, 2009
    (4) Public Health Agency of Canada. Cancer Surveillance Online.
    http://dsol-smed.phac-aspc.gc.ca/dsol-smed/cancer/index_e.html.
    Accessed August, 11, 2009.
    (5) Rituxan Product Monograph, August 7, 2009
    







For further information:

For further information: Jennifer Dolan, Edelman Canada, (416) 979-1120
ext. 257, jennifer.dolan@edelman.com; Samantha Ouimet, Hoffmann-La Roche
Canada, (416) 542-5538, samantha.ouimet@roche.com

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