Idhifa®

Drug - Idhifa® (enasidenib tablets) [Celgene Corporation]

December 2018

Therapeutic area - Oral Oncology

Initial approval criteria

Patient is 18 years of age or older AND
Patient has diagnosis of acute myeloid leukemia (AML)† AND
Patient has an isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA approved test (e.g., RealTime™ IDH2 Assay) AND
Must be used as single agent therapy AND
- Patient has relapsed or refractory disease OR
- Patient who is ≥ 60 years old and used in place of or is not a candidate for intensive therapy OR will undergo post-remission therapy following response to a previous lower intensity therapy
Initial approval is for 6 moths

Patient continues to meet the criteria above AND
Absence of unacceptable toxicity from the drug AND
Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
Renewal approval is for 6 months

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