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Agios gets FDA green light for Tibsovo for AML

The Food and Drug Administration has approved Agios Pharmaceuticals’ Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic mutation.

This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow.

"Tibsovo is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH1 mutation," FDA's Oncology Center of Excellence director, and acting director of the Office of Hematology and Oncology Products Richard Pazdur, M.D. said. "The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions."

The FDA granted the approval of the RealTime IDH1 Assay to Abbott Laboratories.
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