Posted from: Tuesday, August 07, 2018 - 01:44 PM - Present

Tibsovo Approved to Treat Acute Myeloid Leukemia

July 20, 2018 – The U.S. FDA has approved Tibsovo® (ivosidenib), manufactured by Agios Pharmaceuticals, to treat adult patients who have relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The IDH1 mutation must be verified by an FDA-approved diagnostic test.

Approximately 6% to 10% of AML patients are affected by the IDH1 mutation, which prevents the normal development of blood cells. According to the National Cancer Institute, an estimated 19,520 individuals in the United States will be diagnosed with AML in 2018 and an estimated 10,670 AML patients will die of the disease in the same year. The cancer begins in the bone marrow and progresses rapidly. Although AML can be treated, relapses are common. A patient’s prognosis is often poor once a relapse has occurred.

In a clinical study, 32.8% of patients with R/R AML and a confirmed IDH1 mutation who received Tibsovo experienced either complete remission (CR) or complete remission with partial hematologic improvement (CRh). The median length of response was 8.2 months. Recommended dosing is 500mg twice daily until treatment intolerance or disease progression. Tibsovo carries a black box warning that it may cause differentiation syndrome, a potentially fatal condition. Patients who exhibit symptoms of differentiation syndrome should be closely monitored.

Agios has launched Tibsovo at an average wholesale price (AWP) of $31,338 per month.

 

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Last Updated Monday, October 15, 2018 - 12:49 PM.