Regulatory approval

Published by the Food and Drug Administration. Approved

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 myelodysplastic syndromes.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) IDH1 p.R132C Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132G Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132H Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132L Myelodysplastic Syndromes Ivosidenib
FDA (1) IDH1 p.R132S Myelodysplastic Syndromes Ivosidenib