Breast cancer drug Avastin doesn’t extend life, FDA says
WASHINGTON — Federal health scientists said Friday that follow-up studies of a Roche breast cancer drug showed that it failed to extend patients’ lives, opening the door for it to be withdrawn from use in treating the disease.
The Food and Drug Administration approved Roche’s blockbuster Avastin in 2008 based on a trial showing that it slowed growth of tumors caused by breast cancer.
The decision was controversial because drugs for cancer patients who have never been treated usually must show evidence that 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 with 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 and fatigue, the FDA said.