WASHINGTON— Federal regulators took the highly unusual step Thursday 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 said 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.
"With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug," said Sen. David Vitter, R-La. "We can't allow this government takeover of health care to continue any further."
The decision comes as Medicare is in the midst of an unusual review to determine whether to pay for the first vaccine approved to fight prostate cancer. The vaccine, called Provenge, costs about $93,000 per patient.
Avastin was the first drug designed to fight cancer by blocking blood flow to tumors, which has been hailed as one of the first significant innovations in decades in the war on cancer. But Avastin is also one of the most costly of a new generation of anticancer medications that only appear to eke out a few extra months of life and have stirred debate about their cost.
The prospect of the FDA revoking Avastin's approval prompted several members of Congress to send protest letters to the FDA and the Department of Health and Human Services.
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 lived longer or experienced an improved quality of life.
The FDA approved Avastin under a special program designed to make new treatments available as quickly as possible, with the caveat that pharmaceutical companies conduct studies validating their drug's effectiveness.
But an FDA advisory committee voted 12 to 1 on July 20 to withdraw Avastin's authorization for advanced breast cancer. The recommendation was based on two new studies that the advisers concluded had not shown that the drug extends life and indicated the drug slowed tumor growth for perhaps as little as about a month. Avastin can cause potentially serious side effects, including blood clots, bleeding and heart failure.
The decision was praised by cancer experts and by advocates for breast cancer patients. But the possibility of Avastin losing authorization for breast cancer prompted despair among other advocates, some doctors treating patients and women taking the drug, including some who started petition drives to persuade the FDA to ignore the panel's recommendation.
The company disputes the committee's interpretation of the studies, saying they demonstrated that the drug reduced the risk of a woman's cancer progressing or her risk of death from the cancer by 31 to 52 percent.