TIBSOVO (ivosidenib tablets), for oral use. Initial U.S. Approval: 2018

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TIBSOVO (ivosidenib tablets), for oral use. Initial U.S. Approval: 2018

INDICATIONS AND USAGE
TIBSOVO 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.
DOSAGE FORMS & STRENGTHS
Tablets: 250 mg
Manufactured By: Agios Pharmaceuticals
Prescribing Information URL: Click Here

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Ivosidenib, sold under the brand name Tibsovo, is a medication for the treatment of acute myeloid leukemia (AML). It is a small molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), which is mutated in several forms of cancer. The drug is being developed by Agios Pharmaceuticals and is in phase III clinical trials.[when?] The U.S. Food and Drug Administration (FDA) awarded orphan drug designation for acute myeloid leukemia and cholangiocarcinoma.
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.
In 2018, ivosidenib was approved in the United States for relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation and is presently[when?] in a phase III clinical trial for cholangiocarcinoma with an IDH1 mutation.
In 2019, ivosidenib was approved in the United States for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

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