IDHIFA® (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Prognosis in R/R AML
R/R AML IS A CHALLENGING DISEASE WITH POOR OUTCOMES AND A POOR PROGNOSIS1-3
The majority of patients with AML will eventually relapse or become refractory to initial therapy.
IDHIFA® was studied in an open-label, single-arm, multicenter, clinical trial of patients who had R/R AML with an IDH2 mutation who were assigned a starting dose of 100 mg daily until disease progression or unacceptable toxicity. Dose reductions were allowed to manage adverse events. Patients’ IDH2 mutations were either prospectively identified or retrospectively confirmed by the Abbott RealTime™ IDH2 assay. Patients were a median of 68 years old and had a median of 2 prior therapies. Efficacy was established on the basis of the rate of CR/CRh, the duration of CR/CRh, and the rate of conversion from transfusion dependence to transfusion independence. The median follow-up was 6.6 months (range, 0.4 to 27.7).
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