Regulatory approval
Published by the Food and Drug Administration.
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 is written in the approval document as:
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| 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 |