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Targeted AML drug Idhfa gets FDA OK

Aug. 3, 2017Celgene and Agios Pharmaceuticals announced FDA approval of Idhfa (enasidenib) for the treatment of adult patients with relapsed or refractory AML with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test. Idhfa, an oral targeted inhibitor of the IDH2 enzyme, is the first FDA-approved therapy for patients with relapsed or refractory AML and an IDH2 mutation, according to a statement released by the companies.

“The FDA approval of Idhfa provides the first-ever treatment option for patients living with relapsed or refractory AML and an IDH2 mutation. We appreciate the FDA’s efforts to expedite the availability of Idhfa for patients with this devastating disease weeks ahead of the PDUFA date,” Mark Alles, chief executive officer of Celgene, said in the statement. “This milestone further illustrates the value of Celgene’s unique distributed research model. Our partnership with Agios is an exceptional example of how Celgene and its collaborators can positively impact the lives of patients with high unmet needs.”

AML is a blood and bone marrow cancer marked by rapid disease progression and is the most common acute leukemia that affects adults, with more than 21,000 new cases estimated in the U.S. each year. The majority of patients with AML eventually experience relapse. Relapsed or refractory AML has a poor prognosis. For eight to 19 percent of AML patients, the mutated IDH2 enzyme blocks normal blood cell development and results in an overabundance of immature blood cells.

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