Dec. 16--The Food and Drug Administration on Thursday moved toward revoking approval of the blockbuster cancer drug Avastin as a treatment for breast cancer, drawing criticism for limiting treatment options for desperately ill women.
WASHINGTON -- The Food and Drug Administration on Thursday moved toward revoking approval of the blockbuster cancer drug Avastin as a treatment for breast cancer, drawing criticism for limiting treatment options for desperately ill women.
Janet Woodcock, head of the FDA's drug-approval office, told reporters that four studies indicated that Avastin did not prolong life. "None of the trials showed an improvement in overall survival," Woodcock said in an unusually long and detailed news conference that highlighted the sensitivities surrounding the debate over the drug.
Existing approvals of Avastin --the world's best-selling cancer drug -- as a treatment for colon, brain, lung and kidney cancer are not affected by the FDA announcement.
The stage for the revocation of Avastin as a breast cancer treatment was set in July, when an FDA advisory committee voted 12-1 to recommend that the agency yank its approval to market the drug for that purpose, citing the clinical trials that showed no benefit.
The recommendation was made in the wake of passage of the healthcare overhaul and was seized upon by opponents of the new law as evidence of a step toward rationing healthcare.
One of those opponents, Sen. David Vitter (R- Louisiana) noted that if the FDA removed its imprimatur, Avastin, which costs thousands of dollars per month, would only be available through so-called "off-label" prescribing and thus not covered by most insurance.
Vitter on Thursday urged the FDA to reverse course and declared in a press release that the agency "has chosen to place itself between patients and their doctors by rationing access to a life-extending drug."
Avastin also has supporters among breast cancer advocacy groups, including one of the biggest, the Susan G. Komen Foundation, which issued a statement calling for continued coverage of the drug for women who are benefitting from it.
But others said Avastin doesn't work for breast cancer and lauded the FDA for taking steps to limit its use. "I think the FDA acted correctly," said Richard Gralla, a medical oncologist and professor of medicine at the Hofstra University-North Shore LIJ Medical School. "This is not about cost. This is about whether a drug truly benefits people. Why would we want a drug that is neither safe nor effective?"
Avastin was approved for breast cancer in 2008 under a fast-track process to make promising drugs available, subject to further studies.
That process allows for drug companies to appeal subsequent FDA decisions to withdraw its approval, and Avastin's maker, Genentech, said in a statement on its website that it would do so.
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