Avastin is approved for colon, lung, kidney, and brain cancer. The FDA panel that met Tuesday and Wednesday dealt only with the drug's safety and effectiveness in treating breast cancer. The six-member panel voted unanimously to withdraw approval of the drug for that purpose.
The advisory panel said five studies had not shown enough benefit to justify the risks. FDA Commissioner Margaret Hamburg has final say, but usually follows the recommendation of such panels. There was no word on when she will make a decision.
"We are very disappointed by the committee's recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options," said Hal Barron, Roche's chief medical officer and head of global product development, in a statement.
There are breast cancer patients on both sides of the Avastin debate, which went beyond scientific evidence. Health-care costs are part of fiscal arguments in Washington. Avastin's monthly cost is about $7,300.
Even if Hamburg agrees with the panel, doctors will be free to prescribe Avastin for breast cancer patients "off-label," but there could be less certainty about whether public or private insurers would pay for it.
The FDA evaluates drugs and medical devices. Medicare is the biggest government agency when it comes to paying for patient care, and Medicare spokesman Don McLeod said the FDA action would have no immediate effect on reimbursement.
"If it's still on the market and doctors are still prescribing it, we will continue to pay for it," he said. "We often cover off-label uses of [Medicare] Part B drugs."
