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Roche Pharmaceuticals

Avastin Label Updated Reflecting Confidence in Safety Profile

Basel, Switzerland (ots/PRNewswire)

  • 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.

Contact:

Tina Phelan, Galliard Healthcare, +44-207-663-2254,
tphelan@galliardhealth.com

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