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Friday, February 10, 2012
Astex Pharmaceuticals Inc., of Dublin, Calif., said the FDA's Oncologic Drugs Advisory Committee voted 10 to 3, with one abstention, that data provided for Dacogen (decitabine) did not support a favorable benefit/risk profile in acute myeloid leukemia patients, ages 65 and older, who are not considered candidates for induction therapy. The FDA, which is set to review the supplemental new drug application (sNDA) by March 6, generally follows the recommendation of its advisory panels though it is not obligated to do so.
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