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

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

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.