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Abbott Receives FDA Approval for IDH2 Mutation CDx Alongside AML Drug

NEW YORK (GenomeWeb) – The US Food and Drug Administration announced it has approved Abbott Laboratories' companion diagnostic for identifying acute myeloid leukemia patients who have IDH2 gene mutations, and who could benefit from treatment with a new Celgene therapy called Idhifa.

The RealTime IDH2 Assay, which runs on Abbott's m2000 RealTime PCR instrument, detects mutations in patients' blood or bone marrow samples. The test was used to detect IDH2 mutations in nearly 200 patients with relapsed or refractory AML who received Idhifa (enasidenib) as part of a study, which resulted in the approval of the drug and companion diagnostic.

Within six months of treatment, 19 percent of patients had no evidence of disease and a full blood count recovery for a median 8.2 months, and 4 percent of patients had no evidence of disease with partial recovery of blood counts for a median of 9.6 months. One third of 157 patients who needed blood or platelet transfusions at the start of the study didn't require transfusions following treatment with Idhifa. The drug label includes a boxed warning for an adverse reaction known as differentiation syndrome, which can be fatal without treatment.

According to the National Cancer Institute, more than 21,300 people will be diagnosed with AML this year and more than 10,500 patients will die due to the disease. Between 8 percent and 19 percent of AML patients have IDH2 mutations.