FDA approves Celgene and Agios' acute myeloid leukaemia drug

05:53 EDT 2 Aug 2017 | Pharmafile

The FDA has given its approval for the commercialisation of Celgene and Agios Pharmaceutical’s Idhifa for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients with an IDH2 mutation, it has emerged.

Idhifa is an isocitrate dehydrogenase-2 (IDH2) inhibitor which works by blocking a number of enzymes which promote cell growth. Mutations in the IDH2 gene are identified in blood or bone marrow samples using RealTime IDH2 Assay, a companion diagnostic, and the drug is approved for use with this tool.

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Original Article: FDA approves Celgene and Agios' acute myeloid leukaemia drug


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