WASHINGTON The best-selling cancer drug in the world comes under federal scrutiny once again this week, as drugmaker Roche makes a last-ditch effort to keep Avastin approved for breast cancer, despite the government's opinion that it is ineffective against the disease.The two-day meeting at the Food and Drug Administration 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.
Experts say the fact that the agency granted another hearing on the issue is testament to the difficulty of withdrawing approval of a cancer therapy."It says to me that either they've gotten a great deal of negative feedback from various quarters, or there's some kind of internal disagreement within the agency," said Dr. Gary Lyman, professor at the Duke Cancer Institute in North Carolina. Lyman was part of the majority of FDA advisers who voted 12-1 to revoke Avastin's approval last July.
Roche faces a smaller and even tougher panel this Tuesday: five out of six panelists voted against the drug last year. Only one voting member is new. The other panelists either couldn't make the hearing or were recused because of potential conflicts of interest. The FDA weighs the advice of its panels, though agency commissioner Margaret Hamburg will make the final decision.
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