FDA revokes approval for late-stage breast cancer treatment

The Food and Drug Administration recommended revoking approval of an expensive drug for treating late-stage breast cancer two years after approving it.
The agency said it made the recommendation after reviewing clinical studies that showed Avastin does not prolong overall survival in breast cancer patients or sufficiently slow the disease’s progression. The FDA rejected speculation the decision was based on the treatment’s cost, which can run upwards of $90,000 each year.

“The FDA did not consider the cost of Avastin,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, during a Thursday morning call with reporters.
The Centers for Medicare and Medicaid Services will wait for the resolution of the appeals process before considering any changes to its reimbursement policy, Woodcock said. The recommendation will not have any immediate affect on use or prescription of the drug for breast cancer, she said, adding that oncologists should use their judgment whether to continue prescribing the treatment.

Genentech, Avastin’s manufacturer, has 15 days to request a hearing to dispute the agency’s recommendations.

The decision did not come as a surprise after an FDA advisory panel voted 12-1 in July to revoke approval. The recommendation has no affect on Avastin’s other approved uses.