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
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
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
"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.
To learn more about Avastin, visit the
U.S. National Library of Medicine.