By MATTHEW PERRONE, AP Business Writer, 17 July, 10
WASHINGTON – Follow-up studies of a Roche breast cancer drug showed that it failed to extend the lives of patients, federal health scientists said Friday, opening the door for it to be potentially withdrawn for use in treating that disease.
The Food and Drug Administration approved Roche's blockbuster Avastin in 2008 based on a trial showing it slowed growth of tumors caused by breast cancer. The decision was controversial because drugs for cancer patients who have never been treated before must usually show evidence they extend lives.
Avastin's so-called "accelerated approval" was based on the condition that later studies would show a survival benefit.
But in briefing documents posted online, FDA reviewers said two follow-up studies recently submitted by Roche failed to show that Avastin significantly extended lives compared to chemotherapy alone.
Additionally, the FDA said that in follow-up studies the drug did not slow tumor growth to the same degree as in earlier studies.
Patients taking Avastin showed significantly more side effects, including high blood pressure, fatigue and abnormal white blood cell levels.
On Tuesday the FDA will ask a panel of outside cancer experts to review the evidence on Avastin. The panel's recommendations are not binding, but the FDA usually follows their guidance.
The FDA has the option to remove the drug's approval for breast cancer.
Avastin is also approved for colon, lung, kidney and brain cancer. The drug was Roche's top-selling cancer treatment last year with global sales of $5.9 billion.
Roche is headquartered in Basel, Switzerland, and its biotech unit Genentech is based in South San Francisco.
Avastin was the first drug to fight cancer by stopping nutrients from reaching tumors. Such "targeted therapies" were thought to hold promise for eliminating chemotherapy, but the two approaches are now used in combination.
Since 1992, the FDA has granted accelerated approval to drugs based on so-called surrogate endpoints, or initial measures that suggest the drug will make real improvements in patient health. For cancer drugs, tumor shrinkage is considered a predictor of increased survival.
Drugmakers favor the program because it helps them get products to market sooner.
But the program has not escaped criticism from government watchdogs.
Last fall the Government Accountability Office issued a report saying the FDA should do more to track whether drugs approved based on preliminary results actually have live up to their promise.
According to the GAO, the FDA has never once pulled a drug off the market due to missing or unimpressive follow-up data.
Several of the more than a dozen Avastin related posts from Natural Health News
Mar 03, 2008
22, 2008, top administrators of the Food and Drug Administration (FDA) approved the drug Avastin for the treatment of advanced breast cancer. Avastin, which has already been approved for colon and lung cancer, is controversial because ...
Nov 19, 2008
We reported earlier this year that the FDA approved Avastin, manufactured by Genentech, for breast cancer treatment. It had been previously approved for colon and lung cancer treatment. ...
Dec 17, 2007
Last week, the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) voted 5-4 to recommend against approving the drug Avastin for first-line use in advanced breast cancer. In clinical trials to date, ...