Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document as:

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.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	IDH1 p.R132C	Acute Myeloid Leukemia	Olutasidenib
FDA (2)	IDH1 p.R132G	Acute Myeloid Leukemia	Olutasidenib
FDA (2)	IDH1 p.R132H	Acute Myeloid Leukemia	Olutasidenib
FDA (2)	IDH1 p.R132L	Acute Myeloid Leukemia	Olutasidenib
FDA (2)	IDH1 p.R132S	Acute Myeloid Leukemia	Olutasidenib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2022-12-01	Food and Drug Administration	Indication received traditional approval.