Enasidenib: First Global Approval

  title={Enasidenib: First Global Approval},
  author={Esther S. Kim},
  • E. Kim
  • Published 6 September 2017
  • Medicine, Biology
  • Drugs
Enasidenib (Idhifa®) is an oral isocitrate dehydrogenase-2 (IDH2) inhibitor developed by Celgene Corporation under a global, exclusive license from Agios Pharmaceuticals. Enasidenib has been approved in the USA for the treatment of adults with relapsed or refractory acute myeloid leukaemia (AML) and an IDH2 mutation as detected by an FDA-approved test. It is at various stages of development in other countries for AML, myelodysplastic syndromes and solid tumours. This article summarizes the… 
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Isocitrate dehydrogenase inhibitors in acute myeloid leukemia
In recent years, IDH inhibitors have shown good clinical response in AML patients, and enasidenib and ivosidenib, the IDH2 and IDH1 inhibitors developed by Agios Pharmaceuticals, have been approved by the Food and Drug Administration on 1 August 2017 and 20 July 2018 for the treatment of adult relapsed or refractory (R/R) AML with IDH/IDH1 mutations.
Enasidenib in the treatment of relapsed/refractory acute myeloid leukemia: an evidence-based review of its place in therapy
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This review will focus on the biological roles of IDH2 mutation in tumorigenesis, and provide a proof-of-principle for the development and application of IDh2 mutant inhibitors for human cancer treatment.
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The development of wild-type IDH inhibitors is expected to improve the understanding of a potential non-oncogenic addition to IDH1/2 activities and to fully address their applicability in combination with other therapies.
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Enasidenib induces acute myeloid leukemia cell differentiation to promote clinical response.
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Isocitrate dehydrogenase mutations in myeloid malignancies
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Acute Myeloid Leukemia.
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New data from phase 1/2 trial of oral IDHIFA (enasidenib) demonstrate durable complete responses in patients with IDH2 mutant relapsed or refractory AML [media release
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  • 2017
Agios Pharmaceuticals announces initiation of a phase 1/2 clinical trial of AG-221 in patients with advanced solid tumors with an IDH2 mutation [media release
  • http://www.agios.com/
  • 2014
Agios Pharmaceuticals announces that Celgene exercised its option to license AG-221 under global strategic collaboration [media release
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Celgene and Agios extend cancer metabolism collaboration [media release
  • 2011
Celgene Corporation and Agios Pharmaceuticals announce global strategic collaboration to advance unique science of cancer metabolism
  • [media release]
  • 2010