Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to ivosidenib 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:

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

Citation

Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf. Revised October 2023. 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	Ivosidenib
FDA (2)	IDH1 p.R132G	Acute Myeloid Leukemia	Ivosidenib
FDA (2)	IDH1 p.R132H	Acute Myeloid Leukemia	Ivosidenib
FDA (2)	IDH1 p.R132L	Acute Myeloid Leukemia	Ivosidenib
FDA (2)	IDH1 p.R132S	Acute Myeloid Leukemia	Ivosidenib

Contributions

Date	Contributor	Description
2025-06-26	Van Allen lab	Resolving statements mapped to incorrect propositions
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-07-20	Food and Drug Administration	Indication received traditional approval.