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
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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