1 August 2017 - The U.S. FDA today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia who have a specific genetic mutation. 

The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with acute myeloid leukaemia.

Idhifa was granted priority review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. Idhifa also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Idhifa to Celgene Corporation. The FDA granted the approval of the RealTime IDH2 Assay to Abbott Laboratories.

Read FDA press release