Rezlidhia (olutasidenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Metrics Contract Services. Rezlidhia (olutasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215814s000lbl.pdf. Revised December 2022. Accessed October 30, 2024.

Regulatory approvals

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

Indication	Statements
REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.	5

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	IDH1 p.R132C	Acute Myeloid Leukemia	Olutasidenib
Sensitivity (+)	IDH1 p.R132G	Acute Myeloid Leukemia	Olutasidenib
Sensitivity (+)	IDH1 p.R132H	Acute Myeloid Leukemia	Olutasidenib
Sensitivity (+)	IDH1 p.R132L	Acute Myeloid Leukemia	Olutasidenib
Sensitivity (+)	IDH1 p.R132S	Acute Myeloid Leukemia	Olutasidenib