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AUGUST 2, 2017

FDA Approves Idhifa and RealTime IDH2 Assay for Relapsed or Refractory AML

By PPN News Staff

The FDA approved enasidenib (Idhifa, Celgene) to treat adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay (Abbott Laboratories), which is used to detect specific mutations in the isocitrate dehydrogenase-2 (IDH2) gene in patients with AML.

Enasidenib is an IDH2 inhibitor that works by blocking several enzymes that promote cell growth.