Speedy approval for Celgene and Agios' AML drug

Swift work from US biotech Celgene (Nasdaq: CELG), cancer metabolism specialist Agios Pharmaceuticals (Nasdaq: AGIO) and the US Food and Drug Administration (FDA) has led to the approval of a new targeted treatment for relapsed or refractory (R/R) acute myeloid leukemia (AML) in the USA.

The FDA has approved Idhifa (enasidenib) for the treatment of adults with R/R AML who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

"The approval of Idhifa just four years after entering the clinic is the first of what we expect to be multiple first-in-class precision medicines for cancer and rare genetic diseases from our productive discovery engine"