A panel advising the Food and Drug Administration voted against an appeal by Genentech to preserve the approval of Avastin as a treatment for advanced breast cancer.
In unanimous votes on three questions, the six voting members of the panel concluded that Avastin is ineffective and unsafe for breast cancer and that the agency should withdraw its approval for breast cancer treatment even if Genetech proceeds with additional studies.
The ultimate decision rests with FDA Commissioner Margaret Hamburg.
In a written statement, Genentech's Chief Medical Officer Dr. Hal Barron said the company was "very disappointed" by the outcome and hopes "the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options."
Callous bureaucrats are trying to steal away their hope. That's the way several dozen protesters outside the Food and Drug Administration's headquarters yesterday saw it.
Inside another 20 breast cancer patients and their supporters stepped up to microphones to plead with the agency, sometimes tearfully, not to withdraw approval of Avastin, an $88,000-a-year drug they're convinced has prolonged their lives.
In a controversial 2008 decision, the agency gave a fast-track approval for the pricey drug for breast cancer treatment based on a single study, but Genentech, maker of Avastin, was required to continue research on the drug.
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