TREATING PATIENTS HARBORING AN ISOCITRATE DEHYDROGENASE-1 (IDH-1) MUTATION
Methods of treating patients diagnosed with AML or MDS harboring mutant IDH-1 include detecting an IDH1 mutation and the therapeutic administration of an inhibitor of a mutant IDH-1 as a single agent, or in combination with azacitidine (AZA) or cytarabine.
1 . A method of treating a subject having acute myeloid leukemia harboring an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test, comprising administering to the subject 300 mg of olutasidenib per day.
2 . The method of claim 1 , wherein the olutasidenib is administered once daily.
3 . The method of claim 1 , wherein the olutasidenib is administered twice daily.
4 . The method of claim 1 , wherein the olutasidenib is orally administered to the patient.
5 . The method of claim 1 , wherein the olutasidenib is administered in the form of a Type A solid form.
6 . The method of claim 1 , wherein the olutasidenib is administered in a 150 mg strength unit dosage form.
7 . The method of claim 1 , wherein the olutasidenib is administered for a minimum of 6 months.
8 . The method of claim 1 , wherein the IDH1 mutation is a R132X mIDH-1 mutation.
9 . The method of claim 1 , wherein the IDH1 mutation is selected from the group consisting of R132C, R132H, R132S, R132G, and R132L.
10 . The method of claim 1 , further comprising administering azacitidine, cytarabine or both to the subject.
11 . The method of claim 1 , wherein the acute myeloid leukemia is relapsed.
12 . The method of claim 1 , wherein the acute myeloid leukemia is refractory.
13 . A method, comprising identifying a subject with acute myeloid leukemia harboring an isocitrate dehydrogenase-1 (IDH1) mutation, and treating the subject with a total of 300 mg of olutasidenib per day.
14 . The method of claim 13 , wherein the olutasidenib is administered once daily.
15 . The method of claim 13 , wherein the olutasidenib is administered twice daily.
16 . The method of claim 13 , wherein the olutasidenib is orally administered to the patient.
17 . The method of claim 13 , wherein the olutasidenib is administered in the form of a Type A solid form.
18 . The method of claim 13 , wherein the olutasidenib is administered in a 150 mg strength unit dosage form.