Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope.
The debate over Avastin, prescribed to about 17,500 women a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?
The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the expensive drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded.
Citing a dearth of evidence of the drug's effectiveness vs. its potential toxic side effects and its high cost, many cancer experts, patient advocates and others are welcoming the prospect that Avastin's authorization for breast cancer might be repealed. But the possibility is alarming other cancer specialists, patients, some members of Congress and advocates for giving patients access to as many treatments as possible.
The FDA is not supposed to consider costs in its decisions, but if the agency were to rescind approval, insurers are likely to stop paying for treatment.
Avastin is the best-selling cancer drug in the world, with global sales of $5.4 billion, and it is the best-selling product for Roche, whose Genentech unit makes it.
The FDA endorsed Avastin for advanced breast cancer in 2008 despite divided opinion about its usefulness for that purpose. Only one study had found that the drug appeared to delay an advanced breast tumor from growing by about five months. It remained unclear whether patients actually lived longer or experienced an improved quality of life.