The best-selling cancer drug in the world comes under federal scrutiny once again this week, as drug maker Roche makes a last-ditch effort to keep its drug Avastin approved for breast cancer, despite evidence that it is ineffective against the disease.
The two-day Food and Drug Administration meeting is unprecedented since the agency has already ruled against the drug, saying it neither extends nor improves life for breast cancer patients. Roche has taken the rare step of challenging government regulators.
Switzerland-based Roche says it needs more time to study which patients respond to Avastin. But that argument may fall on deaf ears: Five out of six FDA panelists have already voted against the drug. The ultimate decision will be made by FDA Commissioner Margaret Hamburg. (Sapa, June 2011)