WASHINGTON — The Food and Drug Administration moved Thursday to withdraw approval of the blockbuster drug Avastin for breast cancer patients because four recent studies showed it does not extend their lives.
The FDA had approved the drug in 2008 under a special accelerated evaluation process that was subject to further review.
Janet Woodcock, head of the FDA's drug approval office, said the agency was taking action because "none of the trials showed an improvement in overall survival."
Critics accused the FDA of limiting treatment options for desperately ill women, and a conservative lawmaker cited the decision as evidence that the Obama administration was rationing health care.
The FDA said cost did not figure into its decision.
Avastin, which works by blocking blood flow to many kinds of tumors, costs $8,800 a month. It is administered intravenously in conjunction with chemotherapy. Side effects can include holes in the nose, stomach and intestines, as well as bleeding and organ failure.
The drug remains FDA-approved to treat colon, brain, lung and kidney cancer.
Woodcock emphasized that the drug was not being removed from the market and that the FDA's action would not have any immediate effect on women being treated with it.
Avastin's advocates argue that the drug helps some people.
"I really would like my patients to be able to receive this drug," said Julie Gralow, a medical oncologist at the Seattle Cancer Care Alliance. "I treat lots of patients, and it's quite clear that a subset of them are going for a long time. Their tumor has stalled."
"FDA's message should be, 'Let's find out who benefits and make it available to them,' " Gralow said.
Woodcock seemed open to that possibility, noting that studies showed Avastin does stall tumor growth even if it does not extend life.