Federal health scientists say follow-up studies of a Roche breast cancer drug show it failed to slow tumor growth or extend patient lives, opening the door for a potential halt in sales.
The Food and Drug Administration approved Roche's blockbuster Avastin in 2008 based on early-stage trials showing it shrank tumors caused by breast cancer. The approval was controversial because such drugs are usually required to show increased survival time for patients.
The FDA says follow-up studies recently submitted by Roche failed to show that Avastin extended lives compared to chemotherapy alone.
On Tuesday the FDA will ask a panel of outside cancer experts to review the evidence on Avastin.
The FDA has the option to remove drug from the market.
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