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FDA Approves Idhifa for Some With Acute Myeloid Leukemia

For adults with relapsed or refractory AML who have an IDH2 genetic mutation

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WEDNESDAY, Aug. 2, 2017 (HealthDay News) -- Idhifa (enasidenib) has been approved by the U.S. Food and Drug Administration to treat adults with a specific genetic mutation that leads to relapsed or refractory acute myeloid leukemia (AML).

The mutation in the IDH2 gene can be diagnosed with a newly approved companion diagnostic, the RealTime IDH2 Assay, the agency said in a news release Tuesday.

Idhifa is designed to block several enzymes that foster cell growth. The drug was clinically evaluated in a trial of 199 patients with relapsed or refractory AML whose IDH2 mutations were detected by the newly approved diagnostic. After a minimum of six months of treatment, 34 percent of trial participants no longer required blood transfusions, the FDA said.

Common side effects of the drug included nausea, vomiting, diarrhea, elevated levels of bilirubin, and loss of appetite. The drug's label will contain a boxed warning of the possibility of differentiation syndrome. Women who are pregnant or breastfeeding shouldn't take the drug, the agency warned.

Idhifa is produced by Celgene Corp., in Summit, N.J. The RealTime IDH2 Assay is produced by Chicago-based Abbott Laboratories.

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