Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that IDH1 p.R132C status confers therapeutic sensitivity to Ivosidenib in patients with Myelodysplastic Syndromes.

The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible IDH1 mutation, as detected by an FDA-approved test.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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.