FDA Approves Celgene Leukemia Drug

Aug 01, 2017

The U.S. Food and Drug Administration (FDA) has given approval to Celgene's Idhifa, an oral treatment for relapsed or refractory acute myeloid leukemia (AML) patients with an IDH2 mutation.

AML originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells.

Idhifa is meant to be taken alongside an Abbott Laboratories test designed to detect the mutation. According to Celgene, the drug is the first and only FDA-approved therapy for patients with an IDH2 mutation, which consist from 8 to 19 percent of AML patients.

The prescribing information for Idhifa includes a boxed warning that an adverse reaction known as differentiation syndrome can occur and can be fatal if not treated.

Read the FDA announcement

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