FDA Oncology Announcements

IDH inhibitor × Clear all

8 Announcements

FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

Drug: Voranigo (vorasidenib) · IDH inhibitor
Condition: CNS

FDA approves ivosidenib for myelodysplastic syndromes

Drug: Tibsovo (ivosidenib) · IDH inhibitor
Condition: Myeloid

FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

Drug: Rezlidhia (olutasidenib) · IDH inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia

Trial: AGILE
Drugs: Tibsovo (ivosidenib) · IDH inhibitor, azacitidine · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

Trial: ClarIDHy
Drug: Tibsovo (ivosidenib) · IDH inhibitor
Condition: Gastrointestinal

FDA approves ivosidenib as first-line treatment for AML with IDH1 mutation

Drug: TIBSOVO (ivosidenib) · IDH inhibitor
Condition: Myeloid

FDA approves ivosidenib for relapsed or refractory acute myeloid leukemia

Drug: Tibsovo (ivosidenib) · IDH inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA granted regular approval to enasidenib for the treatment of relapsed or refractory AML

Drug: IDHIFA (enasidenib) · IDH inhibitor
Condition: Myeloid