Reporting from 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.
FOR THE RECORD:
Avastin: A Dec. 17 article in Section A about the Food and Drug Administration's move to withdraw approval of the drug Avastin for breast cancer patients quoted Diana Zuckerman, president of the National Research Center for Women and Families, as saying, "The evidence is clear. It doesn't work." However, the article omitted her comment that women currently taking Avastin should continue to receive insurance coverage as long as they receive an explanation from the FDA about the drug's risks. —
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 healthcare.
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 per 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.
The drug's maker, Genentech of South San Francisco, has 15 days to challenge the decision, and said it would do so.
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. She invited Genentech to help investigate whether it would be possible to identify patients who would benefit from the drug.
But for the population of breast cancer patients as a whole, Woodcock said, Avastin's toxic side effects overwhelm other factors.
The FDA set the stage for acting against Avastin in July, when an agency advisory committee voted 12 to 1 to recommend that the drug's approval be withdrawn in light of clinical trials that showed no benefit.
That recommendation, coming after passage of the healthcare overhaul, was cited by critics as evidence of healthcare rationing. Opponents of the healthcare law contend it would ration care to save money.
Avastin was approved for use against breast cancer in 2008 under a process created in the 1990s to speed up approval of AIDS drugs. It includes the stipulation that the drug's ultimate fate depends on further studies.
Sen. David Vitter (R-La.) said if the FDA removed its imprimatur, Avastin would only be available through so-called off-label prescriptions and thus would not be covered by most medical insurance policies.
Off-label prescribing, the practice using drugs to treat conditions for which they are not officially approved, is legal and fairly common, but it often requires the patient to foot the bill.
Vitter urged the FDA to reverse course, declaring in a news release that the agency had "chosen to place itself between patients and their doctors by rationing access to a life-extending drug."
One of the most influential breast cancer advocacy groups, the Susan G. Komen Foundation, didn't dispute the FDA's decision, but called for continued insurance coverage of the drug for women who are benefitting from it.
Others took a harder line.
"The evidence is clear. It doesn't work," said Diana Zuckerman, president of the Washington-based National Research Center for Women and Families.
The drug-maker's parent company, the Swiss drug conglomerate Roche, stands to lose money on the decision. Avastin's worldwide sales are $6 billion, with about $1 billion thought to come from breast cancer treatment.
Meanwhile, the European Medicines Agency recommended Thursday that Avastin be used only with one type of chemotherapy, Reuters news agency reported. Britain already refuses to pay for Avastin for advanced breast cancer. That country's healthcare cost agency gave the drug a poor assessment last week.