Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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.