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FDA Approves Ivosidenib for IDH1+ AML

Jason M. Broderick @jasoncology
Published: Friday, Jul 20, 2018

The FDA has approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML).

In a statement on the approval, Hagop M. Kantarjian, MD, professor and chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, said, “AML patients who relapse or are refractory to available therapies have few, if any, treatment options. The clinical study demonstrated that Tibsovo has the potential to deliver strong, durable responses as a single agent and can help patients achieve and maintain transfusion independence. IDH inhibitors represent a new class of noncytotoxic, targeted therapies for AML patients with IDH mutations.”
FDA Grants Approval of TIBSOVO®, the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation. Agios. Published July 20, 2018. Accessed July 20, 2018. https://bit.ly/2mwqScv.

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