FDA Grants Priority Review to Ivosidenib for IDH1+ AML

February 15, 2018 – The FDA has granted a priority review designation to ivosidenib (AG-120) for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy. The new drug application (NDA) was based on findings from a phase I trial that was presented at the 2017 ASH Annual Meeting. In the single-arm trial, patients treated with the FDA- … (leggi tutto)