FDA Approval Sought for Ivosidenib in IDH1+ AML

December 26, 2017 – A new drug application (NDA) has been submitted for ivosidenib (AG-120) for patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy. The NDA was based on findings from a phase I trial, which was presented at the 2017 ASH Annual Meeting. In the single-arm trial, patients treated with the dose of ivosidenib being … (leggi tutto)