Aug. 1 (UPI) -- The U.S. Food and Drug Administration today approved a new drug to treat adults with relapsed or refractory acute myeloid leukemia, or AML.
The National Institutes of Health estimate that 21,380 people will be diagnosed with acute myeloid leukemia and 10,590 patients will die from the disease in 2017.
The FDA approved Idhifa, or enasidenib, to be used with a companion diagnostic, the RealTime IDH2 Assay, which is used to find specific mutations in the IDH2 gene in patients with AML.
"Idhifa is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions."
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Idhifa is an isocitrate dehydrogenase-2 inhibitor that works by blocking several enzymes that promote cell growth. A blood test or bone marrow sample analysis using RealTime IDH2 Assay can identify patients eligible for treatment with Idhifa.
Researchers tested the efficacy of Idhifa in a trial of 199 patients with relapsed or refractory AML who had IDH2 mutations detected by the RealTime IDH2 Assay.
The study revealed that after six months of treatment, 19 percent of patients had complete remission for a median of 8.2 months and 4 percent of patients experienced complete remission with partial hematologic recovery for a median of 9.6 months.
For the 157 patients who required transfusions of blood or platelets due to AML, 34 percent no longer needed transfusions after Idhifa treatment.
