(BASEL, Apr. 1 AsiaNet=연합뉴스)
HOLD UNTIL 01/04/2009 02:30 SYDNEY TIME
- Contraindication for Patients With Untreated Brain Metastases Removed
- For non-US, UK and Austrian Media Only
The European Medicines Agency (EMEA) has removed a restriction in
the product label which prevented the use of Avastin(R) (bevacizumab) in some
patients whose primary cancer has spread to their brain (brain metastases).
The label change is based on safety data which show that the risk of bleeding
in patients with untreated brain metastases is similar for patients who
receive Avastin and those who do not. The updated label supports Avastin's
well established safety profile across various tumour types.
Brain metastases can bleed and potentially cause severe problems for
patients, regardless of any treatment given. These metastases develop when
cancer cells break away from primary tumours in other organs in the body and
travel through the bloodstream to the brain. This occurs most often with lung
cancer but can also occur in breast, skin (malignant melanoma), kidney, and
colon cancers.
Avastin is approved for the treatment of the advanced stages of four of
the most common cancers: colorectal cancer, breast cancer, lung cancer and
renal cell cancer and has already helped more than 500,000 patients with
cancer worldwide.
Commenting on the updated label, Professor Jean-Charles Soria from
Institut Gustave Roussy, Villejuif, France, said: "The fact that the change
to the label is based on a comprehensive safety database gives added
confidence in use of this major cancer treatment for patients with many
different types of cancer."
The EMEA made their decision following review of a number of analyses
from clinical trials, as well as a safety database generated through use of
Avastin for more than a decade. Data were reviewed from randomised,
controlled and open label clinical studies and the company's safety database.
This includes data from the USA where Avastin has never been contraindicated
for use in patients with brain metastases
About Avastin
Avastin is an innovative medicine that limits the growth of blood vessels
feeding cancerous tissues with oxygen and nutrients. It works by blocking
angiogenesis; an important and unique therapeutic target common to most
cancers and which is crucial to cancer growth. There are more than 450
clinical trials underway to investigate the use of Avastin in over 30 tumour
types.
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. 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 http://www.roche.com.
All trademarks used or mentioned in this release are legally protected.
Additional information
To access video clips about Avastin in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com.
SOURCE: Roche
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