FDA turns down Eisai drug application

Agency declines to approve Dacogen for acute myeloid leukemia in certain elderly patients

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

The drug maker said the FDA's decision was due to the primary study not providing convincing evidence of safety and effectiveness for AML. The drug already is approved for treating myelodysplastic syndromes, a group of cancers that result from damage to the cells in the bone marrow that form blood cells.


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