Idhifa (enasidenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	9

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	IDH2 p.R140Q	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R140L	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R140G	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R140W	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R172K	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R172M	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R172G	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R172S	Acute Myeloid Leukemia	Enasidenib
Sensitivity (+)	IDH2 p.R172W	Acute Myeloid Leukemia	Enasidenib