Avastin Label Updated Reflecting Confidence in Safety Profile
BASEL, Apr. 1 /PRNewswire-AsiaNet/ --
- 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
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:
SOURCE: Roche
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