Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that IDH2 p.R140Q status confers therapeutic sensitivity to Enasidenib in patients with Acute Myeloid Leukemia.

The U.S. Food and Drug Administration granted approval to enasidenib 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.

This statement is based on a regulatory approval from the Food and Drug Administration:

IDHIFA is an isocitrate dehydrogenase-2 inhibitor 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.

Citation

Celgene Corporation. Idhifa (enasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209606s006lbl.pdf. Revised December 2023. Accessed October 30, 2024. Celgene Corporation. Idhifa (enasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf. Revised August 2017. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2017-08-01	Food and Drug Administration	Indication received traditional approval.