F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug - NYTimes.com:
Dr. Hamburg’s decision, outlined in a 69-page memorandum, agrees with the unanimous recommendation made by an F.D.A. advisory committee in June, at the end of a two-day hearing at which some women taking the drug pleaded for its continued approval.
"An initial clinical trial that was the basis for the provisional approval showed that Avastin, combined with the drug paclitaxel, which is also known by the brand name Taxol, delayed the progression of disease by about five and a half months, compared to use of paclitaxel alone.
But in subsequent studies, in which Avastin was combined with different chemotherapy drugs, tumor growth was delayed by one to three months. Avastin did not prolong lives at all, nor did it improve quality of life.
Many breast cancer specialists say that Avastin does appear to work very well for some patients, and some advocates have said the drug should be left on the market for the sake of those patients. But Dr. Hamburg said there was no way to determine in advance who those patients were, so many women would use the drug. “The evidence does not justify broad exposure to the risks of this drug,” she wrote."
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Dr. Hamburg’s decision, outlined in a 69-page memorandum, agrees with the unanimous recommendation made by an F.D.A. advisory committee in June, at the end of a two-day hearing at which some women taking the drug pleaded for its continued approval.
"An initial clinical trial that was the basis for the provisional approval showed that Avastin, combined with the drug paclitaxel, which is also known by the brand name Taxol, delayed the progression of disease by about five and a half months, compared to use of paclitaxel alone.
But in subsequent studies, in which Avastin was combined with different chemotherapy drugs, tumor growth was delayed by one to three months. Avastin did not prolong lives at all, nor did it improve quality of life.
Many breast cancer specialists say that Avastin does appear to work very well for some patients, and some advocates have said the drug should be left on the market for the sake of those patients. But Dr. Hamburg said there was no way to determine in advance who those patients were, so many women would use the drug. “The evidence does not justify broad exposure to the risks of this drug,” she wrote."
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