(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.

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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.

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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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