Last month, the FDA's Oncologic Drugs Advisory Committee sifted through data from two subsequent studies. These showed that progression-free survival time ranged from about one month to nearly three months -- even less than the original study -- without extending patients' overall survival. Further, with known risks such as gastrointestinal perforations, bleeding and blood clots, the risk-benefit may not be favorable, the panel said. The panel voted 12 to one to remove the advanced breast cancer indication from Avastin's U.S. label.
Roche doesn't agree, saying the studies showed the drug reduced the risk of progression or death by 31% to 52%.
The agency is set to decide the matter by Sept. 17.
On Monday, Rob Stein of the Washington Post noted cost considerations may play a part in the FDA's decision:
The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?He adds: "The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment."
Doctors are allowed to prescribe treatment for off-label uses, so they may continue to use Avastin to treat breast cancer, even if the FDA revokes the approval. [/u]Whether or not insurers would approve payment is a different story, considering that Avastin is a $50,000 plus a year drug.[/u]