Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that IDH1 p.R132H status confers therapeutic sensitivity to Olutasidenib in patients with Acute Myeloid Leukemia.

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

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.