Celgene, Agios Ready For Enasidenib Launch After Early Approval

01 Aug 2017

Idhifa is the first treatment for AML patients with IDH2 mutations. The drug will be co-commercialized by Celgene and Agios under their 2010 collaboration and is the latter's first regulatory approval.

Digital illustration of Cancer cell in colour background

Celgene Corp. and partner Agios Pharmaceuticals Inc. are ready to quickly capitalize on FDA approval of Idhifa (enasidenib), which came nearly a month earlier than its Aug. 30 priority review user fee date, for a subset of relapsed or refractory acute myeloid leukemia patients, giving Agios its first approved drug and Celgene the initial fruits of a collaboration inked in 2010.

Idhifa, an oral, targeted inhibitor of the isocitrate dehydrogenase-2 (IDH2) enzyme, was approved Aug.1 to treat adult AML patients with...

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