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| Avastin |
However, Avastin, the world's best selling anti-cancer, is still approved to treat certain types of colon cancer, lung, kidney and brain, said the Food and Drug Administration (FDA) in a statement.
"Women who take Avastin for metastatic breast cancer are exposed to potentially deadly side effects," said the director of the FDA Margaret Hamburg, citing the dangers of heart attack, hypertension and potentially fatal bleeding.
"Nor is there evidence that the use of Avastin will help them live longer or improve their quality of life," he said.
This decision is not a surprise: a panel of independent experts consulted by the FDA in June ruled unanimously against the maintenance of market Avastin (bevacizumab) to treat breast cancer in combination with anticancer Taxol (paclitaxel).
Experts stressed then that two clinical studies of Avastin had shown that this drug has risks and did not prolong the survival of women with breast cancer.
In December 2010 the FDA was about to revoke the authorization for prescription of this drug, but Roche and its U.S. subsidiary Genentech, which developed Avastin, appealed this decision, asking for more time to perform other laboratory studies.
Avastin was approved for treating metastatic breast cancer in February 2008 under the accelerated approval program of the FDA.
This program provides early access to promising new drugs to treat serious or life threatening illnesses, while conducting clinical trials to confirm its effectiveness.
In the case of Avastin, accelerated approval was based on the promising results of a study that suggested that it might extend the life of women with advanced breast cancer.
Roche said Friday it was "disappointed" by the FDA decision, but said in a statement that did not affect the use of Avastin to treat metastatic breast cancer in 80 countries.
"Despite this decision, we will begin a new phase 3 clinical trial of Avastin in combination with paclitaxel against cancer-chemotherapy-used in women with metastatic breast cancer who were never treated," he said in this press release Hal Barron, chief medical officer of Roche.
"This way we can eventually find a biomarker that could help identify patients likely to benefit more from Avastin," he added.
Roche had previously said that the combination of Avastin with Taxol "convincingly demonstrated to enable women with metastatic breast cancer live longer without disease progression."
Revocation of Avastin to treat breast cancer could lose one billion dollars a year the group Federer, according to expert estimates.
Avastin sales totaled about 7,000 million dollars in 2010.
The European authorities advocate the use of the drug Avastin to treat advanced breast cancer in combination with Taxol, while the benefits of Avastin with other anti-cancer are uncertain.
