publication date: Jul. 20, 2018

Clinical Roundup FDA approves Tibsovo as first targeted treatment for relapsed or refractory AML

FDA approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic mutation. This first drug in its class (IDH1 inhibitors) is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML. 

The drug is sponsored by Agios Pharmaceuticals Inc. The companion diagnostic, RealTime IDH1 Assay, is sponsored by Abbott Laboratories.

“Tibsovo is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH1 mutation,” said Richard Pazdur, director of the FDA Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products. “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.”

Tibsovo is an isocitrate dehydrogenase-1 inhibitor that works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), leading to differentiation of malignant cells. If the IDH1 mutation is detected in blood or bone marrow samples using an FDA-approved test, the patient may be eligible for treatment with Tibsovo. Today the agency also approved the RealTime IDH1 Assay, a companion diagnostic that can … Continue reading FDA approves Tibsovo as first targeted treatment for relapsed or refractory AML

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