FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

July 20, 2018 – The U.S. Food and Drug Administration today approved ivosidenib tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) 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. “Ivosidenib is a targeted therapy that fills an unmet need for patients with … (leggi tutto)