Panel rejects Dacogen injection for some AML patients


After reviewing the data from a supplemental New Drug Application (sNDA) accepted for review back in July of last year, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10-3 (one abstaining) to recommend against Eisai's request for approval of Dacogen (decitabine) injection as a treatment of acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.

According to the influential FDA panel (whose recommendations the oversight agency is not required to follow, but generally does) the data suppled by Eisai did not support a favorable benefit-risk profile for Dacogen's use in this patient population.

Source: Therapeutics Daily

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