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DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.
The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.
The FDA is expected to reach a decision on the drug by March 6, the companies said.