Enasidenib: First Global Approval.

Abstract:

: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 milestones in the development of enasidenib leading to this first global approval in the USA for the treatment of adults with relapsed or refractory IDH2-mutated AML.

journal_name

Drugs

journal_title

Drugs

authors

Kim ES

doi

10.1007/s40265-017-0813-2

subject

Has Abstract

pub_date

2017-10-01 00:00:00

pages

1705-1711

issue

15

eissn

0012-6667

issn

1179-1950

pii

10.1007/s40265-017-0813-2

journal_volume

77

pub_type

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