FDA Grants Ivosidenib Breakthrough Status for Relapsed/Refractory IDH1+ MDS

December 17, 2019 – The FDA has granted a breakthrough therapy designation to ivosidenib for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes (MDS) who harbor IDH1 mutations. The designation is based on results from an MDS substudy of a phase I trial (NCT02074839) looking at ivosidenib in patients with advanced hematologic malignancies who have IDH1 mutations. In the MDS cohort, findings showed an overall … (leggi tutto)