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FDA Approvals, News & UpdatesLeukemia

Tibsovo Approved for First-Line Treatment of Patients with Acute Myeloid Leukemia and IDH1 Mutation

In May 2019, the FDA approved Tibsovo for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) and an IDH1 mutation, or for patients with AML who are unable to use intensive chemotherapy.
June 2019 Vol 5 No 3

In May 2019, the FDA approved Tibsovo (ivosidenib; from Agios) for the treatment of patients aged 75 or older with newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, or for patients with AML who have comorbidities (other conditions) that preclude them from using first-line treatment with intensive chemotherapy. Tibsovo should be used based on results of an FDA-approved test that confirm the presence of a susceptible IDH1 mutation. Tibsovo was originally approved by the FDA in 2018 for patients with relapsed or refractory AML and a susceptible IDH1 mutation.

The new approval for Tibsovo as first-line treatment was based on a clinical trial of patients with newly diagnosed AML and an IDH1 mutation, which was detected by the Abbott RealTime IDH1 Assay. All patients were aged 75 or older or had other conditions that prevented them from using intensive ­chemotherapy. All patients received treatment with Tibsovo. After treatment with Tibsovo, 12 (42.9%) of 28 patients achieved complete disease remission or complete remission with partial hematologic recovery, and 7 (41.2%) of the 17 transfusion-dependent patients achieved transfusion independence lasting 8 weeks or longer.

The most common side effects with Tibsovo are diarrhea, fatigue, rash, decreased appetite, elevated white blood cells, nausea, joint and muscle pain, abdominal pain, shortness of breath, and differentiation syndrome.

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Last modified: July 15, 2019

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