Drugmaker Genentech said Friday that the Food and Drug Administration has granted accelerated approval for Avastin, a drug used for the treatment of breast cancer. Genentech said in a statement that Avastin, when used in conjunction with a certain type of chemotherapy, resulted in a 52% reduction in the risk of disease progression.
An earlier report in the Wall Street Journal said the FDA's decision goes against the recommendation of its advisory panel and marks a "major shift" in the way the agency assesses cancer medicine. The FDA has traditionally approved drugs for late-stage cancer if the drug prolonged or improved the quality of patients' lives, the report indicated. Avastin showed signs that it did neither, the Journal said, citing Genentech's (DNA) application for FDA approval.
The Journal reported that analysts believe that the FDA's decision on Avastin "opens the door for other cancer drugs to be approved for their tumor-shrinking capabilities a trend that worries some health experts."
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