^
    Evidence Level:
    Sensitive: A1 - Approval

    [IDH1 mutation-Myelodysplastic Syndrome-ivosidenib]

    Source:
    FDA
    Test:

    Abbott RealTime IDH1

    Published date:
    10/24/2023
    Excerpt:
    TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test...for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes.
    Evidence Level:
    Sensitive: A1 - Approval

    [IDH1 mutation-Acute Myelogenous Leukemia-olutasidenib]

    Source:
    Rigel Press Release
    Test:

    Abbott RealTime IDH1

    Title:
    Rigel Announces U.S. FDA Approval of REZLIDHIA™ (olutasidenib) for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
    Published date:
    12/01/2022
    Excerpt:
    Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the U.S. Food and Drug Administration (FDA) has approved REZLIDHIA™ (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test....The FDA approval was supported by data from the open-label Phase 2 registrational study evaluating REZLIDHIA monotherapy at a dose of 150 mg twice daily in 153 mIDH1 R/R AML patients.
    Evidence Level:
    Sensitive: A1 - Approval

    [IDH1 mutation-Cholangiocarcinoma-ivosidenib]

    Source:
    FDA
    Test:

    Abbott RealTime IDH1

    Published date:
    08/25/2021
    Excerpt:
    TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with a susceptible IDH1 mutation as detected by an FDA-approved test with...Locally Advanced or Metastatic Cholangiocarcinoma...Locally advanced or metastatic cholangiocarcinoma who have been previously treated.
    Evidence Level:
    Sensitive: A1 - Approval

    [IDH1 mutation-Acute Myelogenous Leukemia-ivosidenib]

    Source:
    FDA
    Test:

    Abbott RealTime IDH1

    Excerpt:
    TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test in:...Adult patients with newly-diagnosed AML who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy...Adult patients with relapsed or refractory AML