FDA approves ivosidenib

FDA approves ivosidenib as first-line treatment for AML with IDH1 mutation

FDA approved ivosidenib (TIBSOVO, Agios Pharmaceuticals, Inc.) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. More Information. May 2, 2019

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-first-line-treatment-aml-idh1-mutation

Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications