IDHIFA® (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory
acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected
by an FDA-approved test.
FOR PATIENTS WITH R/R AML AND AN IDH2 MUTATION
MYELOID DIFFERENTIATION
OPENS UP THE POSSIBILITIES
IDHIFA: The first and only oral, targeted inhibitor of IDH2
23
8.2 mo
%
Rate of complete response
(CR)* or CR with partial
hematologic recovery (CRh)†
Median duration of CR/CRh ‡
n=46/199
(95% CI, 4.3-19.4)
n=46/199
(95% CI, 18%-30%)
34
%
Rate of conversion from
transfusion dependence to
transfusion independence
(RBC and platelet)
n=53/157
IDHIFA was studied in an open-label, single-arm, multicenter, clinical trial of patients with R/R AML and 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 reactions. 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.
* CR was defined as <5% of blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets >100,000/μL and AN