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Enasidenib (Idhifa TM) was approved by the FDA on August 1, 2017 for adult patients with relapsed or refractory Acute myeloid leukemia (AML) (IDH1 m). Detected by the FDA-approved Abbott RealTime IDH2 assay. No EMA approval for enasidenib in AML; only holds historical orphan designation without EU marketing authorization (1, 2, 3)
(1)
(2) fda-approves-new-targeted-treatment-relapsed-or-refractory-acute-myeloid-leukemia
(3)…