European Regulator Gives Positive Opinion For The Use Of Avastin In Combination With Docetaxel For T

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European Regulator Gives Positive Opinion for the use of Avastin in Combination

With docetaxel for the First-Line Treatment of Advanced Breast Cancer


MEDIA RELEASE PR35215


BASEL, June 26 /PRNewswire-Asianet/ --


    

    - For non-US, non-UK and non-Austrian Media


    Patients with advanced (metastatic) breast cancer will be able to benefit

from treatment with Avastin (bevacizumab) as a result of a new broader label

recommendation in Europe, Roche announced today. The positive opinion issued

by the European Committee for Medicinal Products for Human Use (CHMP) is for

the use of Avastin in combination with paclitaxel or docetaxel chemotherapy

for the first-line treatment of patients with metastatic breast cancer.

Avastin was granted European approval for use in combination with paclitaxel

in metastatic breast cancer in March 2007.


    The CHMP positive opinion is based on the results from the pivotal phase

III 'Avastin and Docetaxel' (AVADO) study. Based on the updated analysis the

combination of Avastin and docetaxel resulted in:


    - Up to 49% increase in patient's chance of being alive without their 

      disease progressing ('progression free survival') when treated

      with Avastin plus docetaxel compared to docetaxel alone.


    - Over half the patients were alive without their disease progressing for 

      more than 10 months when treated with Avastin plus docetaxel.


    - In the 1-year survival analysis there were significantly more patients 

      alive when treated with Avastin + docetaxel (84%) compared to docetaxel 

      (76%).


    - Overall survival data, reflecting ~ 45% of events, show no

      difference between the treatment arms.


    - Up to two thirds of patients (64%) receiving Avastin based

      therapy experienced major shrinkage in their tumour.


    - No new safety signals, confirming the safety and

      tolerability profile seen in previous studies.


    'This is the second, large phase III study to confirm that

Avastin in combination with a widely used taxane chemotherapy agent extends

the time in which patients live without disease progression,' said Principal

investigator for AVADO, Dr David Miles, medical oncologist, Mount Vernon

Hospital, UK. 'The CHMP opinion reflects the view that Avastin is an

important part of the breast cancer management strategy and gives us more

flexibility when selecting the treatment with our patients.'


    In addition, based on the results from AVADO the CHMP

recommended that the standard dose of Avastin for the treatment of metastatic

breast cancer remains at 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks.


    Despite the treatment improvements that have already been

made, breast cancer continues to be the leading cause of cancer death in

women under age of 55 and more than one million women are diagnosed each

year, this leading to more than 500,000 deaths from the disease 

worldwide.(1,2)


    In addition to breast cancer, Avastin is approved in Europe

for the treatment of the advanced stages of other three common types of

cancer: colorectal cancer, non-small cell lung cancer and kidney cancer.

These types of cancer collectively cause nearly 3 million deaths each year.

In the US Avastin is now approved for the treatment of four tumour types:

breast, colorectal, glioblastoma, and non-small cell lung cancer (NSCLC).


    About AVADO (BO17708)


    AVADO is an international phase III trial where 736 patients who did not

receive previous chemotherapy for their metastatic breast cancer were

randomised to one of three groups:


    - Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel 100 mg/m2


    - Avastin 15 mg/kg every 3 weeks in combination with docetaxel 100 mg/m2


    - Placebo in combination with docetaxel 100 mg/m2 as control arm


    The primary objective of the study was to demonstrate superiority in

progression free survival of both Avastin containing treatment arms compared

to the control arm. Secondary endpoints for the study included response rate,

duration of response, time to treatment failure, overall survival, 1-year

survival, quality of life, safety and tolerability. Based on the updated

analysis the combination of Avastin and docetaxel resulted in:


    - 49% increase in a patient's chance of being alive without disease

      progression when Avastin was used at a dose of 15 mg/kg every 3 weeks

      compared to docetaxel alone.


    - 25% increase in a patient's chance of being alive without disease

      progression when Avastin was used at a dose of 7.5 mg/kg every 3 weeks

      compared to docetaxel alone.


    - Response rates (percentage of tumour shrinkage) were significantly

      increased only for the 15mg/kg every 3 week Avastin arm [46% 

      (placebo) v 55% (7.5 mg/kg) and 64% (15 mg/kg)].


    - Overall survival data, reflecting ~ 45% of events, show no difference

      between the treatment arms. The pre-specified landmark survival 

      analysis at 1 year is significantly increased only for the 15 mg/kg 

      every 3 week Avastin arm [76% (placebo) v 81% (7.5 mg/kg)] and 84% 

      (15 mg/kg)].


    - No new safety signals related to Avastin were observed. Furthermore,

      Avastin had only a limited impact on the known toxicity profile of 

      docetaxel.


    About Avastin


    Avastin is an antibody that specifically binds and blocks VEGF (vascular

endothelial growth factor). VEGF is the key driver of tumour angiogenesis -

an essential process of development and maintenance of blood vessels which is

required for a tumour to grow and to spread (metastasise) to other parts of

the body. Avastin's precise mode of action helps control tumour growth and

metastases with only a limited impact on side effects of chemotherapy.


    Avastin has proven survival benefits across multiple tumour types.

Avastin is approved in Europe for the treatment of the advanced stages of

four common types of cancer: colorectal cancer, breast cancer, non-small cell

lung cancer and kidney cancer. These types of cancer collectively cause

nearly 3 million deaths each year. In the US, Avastin was the first

anti-angiogenesis therapy approved by the FDA and is now approved for the

treatment of four tumour types: breast, colorectal, glioblastoma, and

Community Health Roche 2 image

non-small cell lung cancer (NSCLC).


    More than 500,000 patients have been treated with Avastin so far. A

comprehensive clinical programme with more than 450 clinical trials is

investigating the use of Avastin in various tumour types (including

colorectal, breast, lung, brain, gastric, ovarian, prostate and others) and

different settings (advanced or early stage disease).


    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 interest in

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



    All trademarks used or mentioned in this release are legally protected.


    References


    1. Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American

Cancer Society, 2007.


    2. WHO Cancer Factsheet No 297 - updated July 2008. Last accessed 24



    For more information please contact: Amy Brice, Roche, +41-61-687-4054 or Jon

Harris, Galliard Healthcare, +44-207-663-2261


    SOURCE: Roche

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