US revokes Roche's Avastin for breast cancer

November 18, 2011

US health officials on Friday revoked the authorization of Roche's Avastin for breast cancer treatment, saying it concluded the drug had "not been shown to be safe and effective for that use."

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer, the US Food and Drug Administration said in a statement.

"This was a difficult decision," FDA Commissioner Margaret Hamburg said.

"FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use."

The latest move followed the recommendation of an expert panel that said the drug, also known under the generic name bevacizumab, carries risks such as severe high blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer.

The FDA had accepted the expert report that Avastin was not an effective treatment for breast cancer but Roche decided to appeal.

Hamburg said studies indicate that women who take Avastin for metastatic breast cancer "risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks."

"Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life," she added.

Avastin, which is marketed in the United States by the firm Genentech for its Swiss parent Roche, was approved for metastatic breast cancer in February 2008 under the FDA's accelerated approval program.

The program provides early access to promising new drugs to treat serious or life-threatening conditions while clinical trials to confirm their efficacy are conducted.

In the case of Avastin, the accelerated approval was based on promising results from one study that suggested it could extend the lives of women with advanced breast cancer.

Genentech said in a statement it was "disappointed with the outcome."

"We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States," said Hal Barron, chief medical officer of the group.

"Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin."

European medical experts have urged that the drug be restricted to use in combination with paclitaxel only instead of other forms of chemotherapy because benefits were uncertain.

Related Stories

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.