FDA Advisers Say Avastin Shouldn't Be Used for Breast Cancer
Posted Jul 20 2010 10:00am
The drug failed to live up to preliminary promise, experts contend.
TUESDAY, July 20 (HealthDay News) -- The cancer drug Avastin should no longer be used as a treatment for breast cancer, a U.S. Food and Drug Administration advisory panel voted Tuesday, saying the drug wasn't benefiting patients.
The 12 to 1 vote represented a setback for Avastin, which is the world's best-selling cancer drug, with sales last year of about $6 billion. Avastin is sold by drug maker Roche's Genentech unit, The New York Times reported.
Earlier Tuesday, the advisory committee said data suggested that at least for breast cancer, the initial data that led to accelerated approval of Avastin in 2008 for breast cancer was not borne out by subsequent studies.
The drug is also approved for lung, colon, kidney and brain cancer, the Associated Press reported.
The 13 experts convened by the FDA voted unanimously that the drug's side effects and risks outweighed benefits when used with conventional chemotherapy.
When the FDA approved Avastin for breast cancer patients in 2008, it was on the condition that Roche provide additional studies supporting evidence that the drug kept the disease from worsening for more than five months.
But two follow-up studies failed to show that same effect, and patients did not gain any survival benefits. But they did experience serious side effects, including fatigue, abnormal white blood cell counts and high blood pressure, the AP reported.
"The study shows there's very little benefit to patients with significant toxicity risks and no clear survival benefit," said Natalie Compagni Portis, the FDA advisory panel's patient representative, the news service reported.
The FDA is not bound to follow the recommendations of its advisory committees, but typically does so.