Health Care

Celgene's leukemia drug wins FDA approval

Celgene's leukemia drug wins FDA approval

The FDA approved Idhifa, or enasidenib, to be used with a companion diagnostic, the RealTime IDH2 Assay, which is used to find specific mutations in the IDH2 gene in patients with AML.

Officials with the FDA have approved enasidenib (Idhifa, Celgene Corporation) for the treatment relapsed or refractory acute myeloid leukemia (AML) in adult patients who have a specific genetic mutation, isocitrate dehydrogenase-2 (IDH2), according to a FDA press release.

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"The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions", said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence. AML is an aggressive, difficult-to-treat rare blood cancer that forms in the bone marrow and leads to increased number of abnormal white blood cells.

More than 20,000 patients are diagnosed with AML in the U.S. yearly and most patients experience relapse; over 50% of cases result in death.

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An IDH2 inhibitor, enasidenib blocks the activity of several enzymes involved in promotion of cell growth.

AML is a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with more than 21,000 new cases estimated in the USA each year.The majority of patients with AML eventually experience relapse. Primary supporting evidence for the drug's approval application came from a single-arm trial involving 199 patients with IDH2-positive relapsed/refractory AML. With a minimum of 6 months of treatment, 19% of patients experienced complete remission for a median 8.2 months, and 4% experienced complete remission with partial hematologic recovery for a median 9.6 months. A third of 157 patients who required transfusions prior to treatment with enasidenib no longer needed transfusions after treatment with the IDH2 inhibitor.

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To score goals is to be in the right place in the box when the cross comes in and he has that quality, ' Wenger said. Alexandre Lacazette says he has entered "a new world" since arriving in the Premier League with Arsenal .

The drug's label will contain a boxed warning of a deadly side effect called differentiation syndrome, with possible symptoms including fever, difficulty breathing, lung inflammation and rapid weight gain. The drug is contraindicated for women who are pregnant or breastfeeding.


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