Rob Stein
WASHINGTON -- Federal regulators Thursday took the highly unusual step of moving to revoke approval of a drug to treat advanced breast cancer.
The Food and Drug Administration announced plans to withdraw authorization to sell the blockbuster drug Avastin for metastatic breast cancer, saying four new studies indicate the benefits of the drug do not outweigh the risks.
"After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "None of the studies demonstrated that patients receiving Avastin lived longer, and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision."
Avastin is the world's best-selling cancer drug, with global sales of $5.8 billion, and it is the top-selling product for Roche, whose Genentech unit makes it. Its use to treat breast cancer brings in about $855 million in annual revenue in the United States.
The FDA said Genentech had 15 days to request a hearing to review the decision, and the company immediately said in a statement it would request that step. The company maintains the drug does extend the lives of breast cancer patients.
Avastin, which is prescribed to about 17,500 breast cancer patients each year, remains approved to treat several other tumors, including those of the colon, lung, kidney and brain. So doctors can continue to prescribe it for breast cancer as an "off-label" use.
But an FDA revocation would likely prompt insurers to stop paying for Avastin for metastatic breast cancer. Avastin is one of the most expensive cancer drugs, costing about $8,000 a month. Breast cancer patients also would lose eligibility for a program in which Genentech caps the annual cost of the drug at about $57,000 for women making less than $100,000 a year.
The FDA is not supposed to consider cost in making such decisions, and Woodcock told reporters Thursday that cost was not a factor in the decision. But the debate over Avastin has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle to overhaul the health-care system.