Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) IDH2 p.R140Q Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R140L Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R140G Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R140W Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R172K Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R172M Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R172G Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R172S Acute Myeloid Leukemia Enasidenib
FDA (1) IDH2 p.R172W Acute Myeloid Leukemia Enasidenib